Significant New Use Rules on Certain Chemical Substances and Notification on Certain Substances for Which Significant New Use Rules are Not Being Issued, 14681-14708 [E7-5797]
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Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Rules and Regulations
Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. section 804(2).
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by May 29, 2007.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this rule for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping
requirements, and Volatile organic
compounds.
Dated: February 27, 2007.
Steve Rothblatt,
Acting Regional Administrator, Region 5.
For the reasons stated in the preamble,
part 52, chapter I, of title 40 of the Code
of Federal Regulations is amended as
follows:
I
PART 52—[AMENDED]
1. The authority citation for part 52
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
Subpart P—Indiana
2. Section 52.770 is amended by
removing and reserving paragraphs
(c)(91) and (c)(166), and adding
paragraph (c)(178) to read as follows:
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I
§ 52.770
*
Identification of plan.
*
*
(c) * * *
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*
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14681
(178) On August 25, 2006, Indiana
submitted final adopted revisions to its
emission reporting requirement rules as
a revision to the Indiana State
Implementation Plan.
(i) Incorporation by reference. Indiana
Administrative Code Title 326: Air
Pollution Control Board, Article 2:
Permit Review Rules, Rule 6 Emission
Reporting, Section 1: Applicability,
Section 3: Compliance schedule, and
Section 4: Requirements. Approved by
the Attorney General June 29, 2006.
Approved by the Governor July 13,
2006. Filed with the Publisher July 14,
2006. Published on the Indiana Register
Web site August 9, 2006, Document
Identification Number (DIN):20060809–
IR–326050078FRA. Effective August 13,
2006.
Gasoline Program effective as of May 1,
2007. That action would have amended
our regulations to make the Illinois
portion of the St. Louis, IllinoisMissouri ozone nonattainment area a
covered area and prohibit the sale of
conventional gasoline. We stated in that
Federal Register document that if we
received adverse comment by January
26, 2007, we would publish a timely
notice of withdrawal in the Federal
Register. We subsequently received an
adverse comment.
We will address the comment in a
subsequent final action based on the
parallel proposal also published on
December 27, 2006 (71 FR 77690). As
stated in the parallel proposal, we will
not institute a second comment period
on this action.
[FR Doc. E7–5655 Filed 3–28–07; 8:45 am]
BILLING CODE 6560–50–P
Dated: March 22, 2007.
Stephen L. Johnson,
Administrator.
ENVIRONMENTAL PROTECTION
AGENCY
PART 80—REGULATION OF FUELS
AND FUEL ADDITIVES
40 CFR Part 80
§ 80.70
[FRL–8293–1]
I
Regulation of Fuels and Fuel
Additives: Extension of the
Reformulated Gasoline Program to the
East St. Louis, IL Ozone Nonattainment
Area
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
[Amended].
Accordingly, the amendment to 40
CFR 80.70 which was published in the
Federal Register on December 27, 2006
(71 FR 77615) is withdrawn as of March
29, 2007.
[FR Doc. E7–5808 Filed 3–28–07; 8:45 am]
BILLING CODE 6560–50–P
AGENCY:
SUMMARY: EPA published a direct final
rule on December 27, 2006, to extend
the reformulated gasoline program to
the Illinois portion of the St. Louis
Illinois-Missouri ozone nonattainment
area effective as of May 1, 2007.
However, we received an adverse
comment during the 30 day comment
period and are now withdrawing that
direct final rule.
DATES: As of March 29, 2007, EPA
withdraws the direct final rule
published at 71 FR 77615, on December
27, 2006.
FOR FURTHER INFORMATION CONTACT: Kurt
Gustafson at (202) 343–9219.
SUPPLEMENTARY INFORMATION: Because
EPA received adverse comment, we are
withdrawing the direct final rule for
‘‘Regulation of Fuels and Fuel
Additives: Extension of the
Reformulated Gasoline Program to the
East St. Louis, Illinois Ozone
Nonattainment Area.’’ We published the
direct final rule on December 27, 2006
(71 FR 77615), that would have
approved the State of Illinois’s request
to opt-in to the Federal Reformulated
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2003–0063; FRL–7699–5]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances and Notification
on Certain Substances for Which
Significant New Use Rules are Not
Being Issued
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
SUMMARY: EPA is promulgating
significant new use rules (SNURs) under
section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 65 chemical
substances which were the subject of
premanufacture notices (PMNs).
Thirteen of these chemical substances
are subject to TSCA section 5(e) consent
orders issued by EPA. This action
requires persons who intend to
manufacture, import, or process any of
these 65 chemical substances for an
activity that is designated as a
significant new use by this rule to notify
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EPA at least 90 days before commencing
that activity. The required notification
will provide EPA with the opportunity
to evaluate the intended use and, if
necessary, to prohibit or limit that
activity before it occurs. This direct
final rule also provides notification on
two substances for which EPA has
decided not to issue significant new use
rules at this time.
DATES: The effective date of this rule is
May 29, 2007 without further notice,
unless EPA receives adverse or critical
comments, or notice of intent to submit
adverse or critical comments before
April 30, 2007. This rule shall be
promulgated for purposes of judicial
review at 1 p.m. (e.s.t.) on April 12,
2007.
If EPA receives adverse or critical
comments, or notice of intent to submit
adverse or critical comments, on one or
more of these SNURs before April 30,
2007, EPA will withdraw the relevant
sections of this direct final rule before
its effective date. EPA will then issue a
proposed SNUR for the chemical
substance(s) on which adverse or
critical comments were received,
providing a 30-day period for public
comment.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2003–0063, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
number EPA–HQ–OPPT–2003–0063.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2003–0063. EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
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whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the public docket and made
available on the Internet. If you submit
an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the docket’s index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
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Environmental Assistance Division
(7408M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 554–1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact:
Karen Chu, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8773; e-mail address:
chu.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you manufacture, import,
process, or use the chemical substances
contained in this rule. Potentially
affected entities may include, but are
not limited to:
• Manufacturers, importers, or
processors of one or more subject
chemical substances (NAICS codes 325
and 324110), e.g., Chemical
manufacturing and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
40 CFR 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Persons who import
any chemical substance governed by a
final SNUR are subject to the TSCA
section 13 (15 U.S.C. 2612) import
certification requirements and the
corresponding regulations at 19 CFR
12.118 through 12.127 and 19 CFR
127.28. Those persons must certify that
the shipment of the chemical substance
complies with all applicable rules and
orders under TSCA, including any
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
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that is the subject of this rule on or after
April 30, 2007 are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see 40 CFR
721.20), and must comply with the
export notification requirements in 40
CFR part 707, subpart D.
B. What Should I Consider as I Prepare
My Comments for EPA?
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1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date, and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is promulgating these SNURs
using direct final procedures. These
SNURs will require persons to notify
EPA at least 90 days before commencing
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the manufacture, import, or processing
of a chemical substance for any activity
designated by these SNURs as a
significant new use. Additional
rationale and background to this rule are
more fully set out in the preamble to
EPA’s first direct final SNUR published
in the Federal Register of April 24, 1990
(55 FR 17376). Consult that preamble for
further information on the objectives,
rationale, and procedures for SNURs
and on the basis for significant new use
designations, including provisions for
developing test data.
B. What is the Agency’s Authority for
Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including those listed in TSCA section
5(a)(2). Once EPA determines that a use
of a chemical substance is a significant
new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant
new use notice (SNUN) to EPA at least
90 days before they manufacture,
import, or process the chemical
substance for that use. The mechanism
for reporting under this requirement is
established under 40 CFR part 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
under 40 CFR part 721, subpart A.
These provisions describe persons
subject to the rule, recordkeeping
requirements, exemptions to reporting
requirements, and applicability of the
rule to uses occurring before the
effective date of the final rule.
Provisions relating to user fees appear at
40 CFR part 700. According to 40 CFR
721.1(c), persons subject to these SNURs
must comply with the same notice
requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section
5 (h)(1), (h)(2), (h)(3), and (h)(5), and the
regulations at 40 CFR part 720. Once
EPA receives a SNUN, EPA may take
regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities
on which it has received the SNUN. If
EPA does not take action, the Agency is
required under TSCA section 5(g) to
explain in the Federal Register its
reasons for not taking action.
Persons who export or intend to
export a chemical substance identified
in a proposed or final SNUR are subject
to the export notification provisions of
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TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at
40 CFR part 707, subpart D. Persons
who import a chemical substance
identified in a final SNUR are subject to
the TSCA section 13 import certification
requirements, codified at 19 CFR 12.118
through 12.127 and 19 CFR 127.28.
Such persons must certify that the
shipment of the chemical substance
complies with all applicable rules and
orders under TSCA, including any
SNUR requirements. The EPA policy on
import certification appears at 40 CFR
part 707, subpart B.
III. Substances Subject to this Rule
EPA is establishing significant new
use and recordkeeping requirements for
65 chemical substances under 40 CFR
part 721, subpart E. In this unit, EPA
provides the following information for
each chemical substance:
• PMN number.
• Chemical name (generic name if the
specific name is claimed as CBI).
• CAS number (if assigned for nonconfidential chemical identities).
• Basis for the section 5(e) consent
order, or, for non-5(e) SNURs, the basis
for the SNUR.
• Toxicity concerns.
• Tests recommended by EPA to
provide sufficient information to
evaluate the chemical substance (see
Unit VI. for more information).
• CFR citation assigned in the
regulatory text section of this rule.
The specific activities designated as
significant new uses are listed in the
regulatory text section of 40 CFR part
721, subpart E. Certain new uses,
including production limits and other
uses designated in the rule are claimed
as CBI. The procedure for obtaining
confidential information is set out in
Unit VII.
This rule includes SNURs on 13 PMN
substances that are subject to ‘‘riskbased’’ consent orders under TSCA
section 5(e)(1)(A)(ii)(I) wherein EPA
determined that activities associated
with the PMN substances may present
unreasonable risk to health or the
environment. The consent orders
require protective measures to limit
exposures or otherwise mitigate the
potential unreasonable risk. The socalled ‘‘5(e) SNURs’’ on these
substances are promulgated pursuant to
40 CFR 721.160, and are based on and
consistent with the provisions in the
underlying consent orders. The SNURs
designate as a ‘‘significant new use’’ the
absence of the protective measures
required in the consent order.
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
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inhalation exposure, the underlying
section 5(e) consent order usually
requires, among other things, that
potentially exposed employees must
wear specified respirators unless actual
measurements of the workplace air
show that air-borne concentrations of
the PMN substance are below a New
Chemical Exposure Limit (NCEL) that is
established by EPA to provide adequate
protection to human health. In addition
to the actual NCEL concentration, the
comprehensive NCELs provisions in
section 5(e) consent orders, which are
modeled after Occupational Safety and
Health Administration (OSHA)
Permissible Exposure Limits (PELs)
provisions, include requirements
addressing performance criteria for
sampling and analytical methods,
periodic monitoring, respiratory
protection, and recordkeeping.
However, no comparable NCELs
provisions currently exist in 40 CFR
part 721, subpart B for SNURs.
Therefore, for these cases, the
individual SNURs in subpart E state that
persons subject to the SNUR who wish
to pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under 40 CFR 721.30.
Persons whose § 721.30 requests to use
the NCELs approach are approved by
EPA will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order for the same chemical substance
for SNURs.
This rule also includes SNURs on 52
PMN substances that are not subject to
consent orders under TSCA section 5(e).
In these cases, EPA did not find that the
use scenario described in the PMN
triggered the determinations set forth
under section 5(e) of TSCA. EPA,
however, does believe that certain
changes from the use scenario described
in the PMN could result in increased
exposures, thereby constituting a
‘‘significant new use.’’ These so called
‘‘Non-5(e) SNURs’’ are promulgated
pursuant to 40 CFR 721.170. EPA has
determined that every activity
designated as a ‘‘significant new use’’ in
all non-5(e) SNURs issued under 40 CFR
721.170 satisfies the two requirements
stipulated in § 721.170(c)(2), i.e., these
significant new use activities, ‘‘(i) are
different from those described in the
premanufacture notice for the
substance, including any amendments,
deletions, and additions of activities to
the premanufacture notice, and (ii) may
be accompanied by changes in exposure
or release levels that are significant in
relation to the health or environmental
concerns identified’’ for the PMN
substance.
PMN Number P–97–415
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Chemical name: 2-Thiazolidinone.
CAS number: 2682–49–7.
Effective date of section 5(e) consent
order: April 20, 2000.
Basis for section 5(e) consent order: The
PMN states that the substance will be
used as an intermediate. The order was
issued under section 5(e)(1)(A)(i) and
(ii)(I) of TSCA based on a finding that
this substance may present an
unreasonable risk of injury to health and
the environment. To protect against this
risk, the consent order requires worker
protection and hazard communication
and restricts disposal, water releases,
and aggregate manufacture/importation
volume of the PMN substance. It also
prohibits use of the PMN substance
other than as an intermediate and
prohibits domestic manufacturing,
processing, or use of the PMN substance
as a powder. The SNUR designates as a
‘significant new use’ the absence of
these protective measures.
Toxicity concern: EPA has identified
health concerns for high acute toxicity
and signs of neurotoxic effects based on
test data for the PMN substance. EPA
also has concerns for chronic effects and
systemic, developmental, and maternal
toxicity based on test data on a
structurally similar substance. The
NCEL is 0.7 mg/m3 as an 8-hour timeweighted average. EPA is concerned that
toxicity to aquatic organisms may occur
at concentrations as low as 300 parts per
billion (ppb) of the PMN substance in
surface waters based on test data on a
structurally similar substance.
Recommended testing: EPA has
determined that the following test
would help characterize the human
health effects of the PMN substance: A
combined repeated dose toxicity with
the reproductive/developmental toxicity
screening test (oral route) (OPPTS
870.3650 test guideline) with a
neurotoxicity functional observational
battery (National Technical Information
Service (NTIS) PB 91–154617) and a
histopathologic examination extended
to include the blood, liver, kidney,
brain, and spinal cord on the PMN
substance to help characterize
neurotoxic, systemic, reproductive, and
developmental effects. The PMN
submitter has agreed not to exceed the
production volume limit without
performing this test. In addition, EPA
has determined that a porous pot test
(OPPTS 835.3220 test guideline), a fish
acute toxicity test (OPPTS 850.1075 test
guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test
guideline (public draft)), and an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
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CFR citation: 40 CFR 721.10002.
PMN Numbers P–98–625/626/627/628/
629 and P–00–614/617
Chemical name: Manganese
heterocyclic tetraamine complex
(generic).
CAS number: Not available.
Basis for action: The PMNs state that the
generic (non-confidential) use of the
substances will be in commercial
research and development. EPA has
identified health concerns for chronic
organ effects based on data on a
structurally similar substance. Since
significant worker exposure is unlikely
at the production volume identified in
the PMNs, EPA has not determined that
the proposed manufacture, processing,
or use of the substances may present an
unreasonable risk. EPA has determined,
however, that a manufacture or
importation volume greater than 10,000
kilograms/year of any one of the PMN
substances may result in serious chronic
effects. Based on this information, each
of the PMN substances meet the concern
criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a 90-day
oral toxicity study (OPPTS 870.3100 test
guideline) would help characterize the
human health effects of the PMN
substances.
CFR citation: 40 CFR 721.10003.
PMN Number P–98–1181
Chemical name: 2-Butenoic acid, 4,4′[(dibutylstannylene)bis(oxy)]bis[4-oxo-,
(2Z,2′Z)-, di-C8-10-isoalkyl esters, C9rich.
CAS number: 247041–56–1.
Basis for action: The PMN states that the
substance will be used as a polyvinyl
chloride stabilizer. EPA has identified
concerns for corrosion to skin, eyes, and
mucuous membranes, neurotoxicity,
blood toxicity, liver toxicity,
immunosupression, reproductive
toxicity, and adrenal effects based on
analogy to organotins. As described in
the PMN, significant worker exposure is
unlikely. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
uses of the substance in a solid form,
involving an application method that
generates a vapor, mist, or aerosol, or
where there is potential dermal
exposure without the use of impervious
gloves, may cause serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a 90-day
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oral toxicity study (OPPTS 870.3100 test
guideline) and a neurotoxicity screening
test (OPPTS 870.6200 test guideline)
would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10004.
PMN Number P–98–1182
Chemical name: 2-Butenoic acid, 4,4′[(dibutylstannylene)bis(oxy)]bis[4-oxo-,
(2Z,2′Z)-, di-C9-11-isoalkyl esters, C10rich.
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CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a polyvinyl
chloride stabilizer. EPA has identified
concerns for corrosion to skin, eyes, and
mucuous membranes, neurotoxicity,
blood toxicity, liver toxicity,
immunosupression, reproductive
toxicity, and adrenal effects based on
analogy to organotins. As described in
the PMN, significant worker exposure is
unlikely. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
uses of the substance in a solid form,
involving an application method that
generates a vapor, mist, or aerosol, or
where there is potential dermal
exposure without the use of impervious
gloves, may cause serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a 90-day
oral toxicity study (OPPTS 870.3100 test
guideline) and a neurotoxicity screening
test (OPPTS 870.6200 test guideline)
would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10005.
PMN Number P–99–511
Chemical name: Mixed metal oxide
(generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as an additive for
coatings. Based on data for a similar
substance, EPA has identified concerns
for cancer, immunotoxicity, and lung
toxicity. As described in the PMN,
significant inhalation exposure is
unlikely. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
a manufacture/importation volume
greater than 60,000 kilograms/year of
the PMN substance may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170
(b)(1)(i)(C) and (b)(3)(ii).
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Recommended testing: EPA has
determined that a bacterial reverse
mutation test (OPPTS 870.5100 test
guideline) and a mammalian erythrocyte
micronucleus test (intraperitoneal route)
(OPPTS 870.5395 test guideline) with
special attention to histopathology of
the lung tissues and organs of the
immune systems (spleen, thymus, bone
marrow) would help characterize the
human health effects of the PMN
substance. If the results of the
recommended tests indicate that the
PMN substance has carcinogenic
potential, a carcinogenicity study
(OPPTS 870.4200 test guideline) would
help further characterize the health
effects.
CFR citation: 40 CFR 721.10006.
PMN Number P–00–11
Chemical name: Alcohols, C12-14 secondary, ethoxylated propoxylated.
CAS number: 103331–86–8.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a household
cleaning agent additive. Based on
analogy to nonionic surfactants, EPA is
concerned that toxicity to aquatic
organisms may occur at concentrations
above 50 ppb in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations above 50
ppb. Thus, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance resulting in surface water
concentrations above 50 ppb may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and an algal toxicity test (OPPTS
850.5400 test guideline (public draft))
would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10007.
PMN Numbers P–00–1121/1122/1123/
1124/1125/1126
Chemical names: (P–00–1121)
Manganese strontium oxide (MnSrO3);
(P–00–1122) Manganese yttrium oxide
(MnYO3); (P–00–1123) Barium
manganese oxide (BaMnO3); (P–00–
1124) Barium calcium manganese
strontium oxide; (P–00–1125)
Manganate (MnO21-), calcium (2:1); and
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(P–00–1126) Manganese yttrium oxide
(Mn2YO5).
CAS numbers: (P–00–1121) 12163–45–
0, (P–00–1122) 12032–75–6, (P–00–
1123) 12230–80–7, (P–00–1124)
359427–90–0, (P–00–1125) 12049–47–7,
and (P–00–1126) 12438–71–0.
Effective date of section 5(e) consent
order: March 23, 2001.
Basis for section 5(e) consent order: The
PMNs state that the generic (nonconfidential) use of the substances will
be as pigments. The order was issued
under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) of TSCA based on a
finding that these substances may
present an unreasonable risk of injury to
human health and the environment. To
protect against this risk, the consent
order requires hazard communication
and restricts aggregate manufacture/
importation volume, particle size and
water releases of the PMN substances.
The SNUR designates as a ‘significant
new use’ the absence of these protective
measures.
Toxicity concern: EPA has health
concerns for neurotoxicity and
mutagenicity for the PMN substances
based on exposure to manganese;
concerns for lung toxicity, fibrosis, and
possible cancer of the lungs due to
potential exposure to the particulate
form of the substances; and concern for
lung effects through lung overload if
respirable particles are inhaled. Based
on test data on structurally similar
substances, EPA is concerned that
toxicity to aquatic organisms for each of
these PMN substances may occur at
concentrations as low as 100 ppb in
surface waters. Further, the Agency has
determined that the PMN substances
may be persistant, bioaccumulative, and
toxic based on physical/chemical
properties of the substances, consistent
with the New Chemical Program’s
Persistant, Bioaccumulative, and Toxic
(PBT) Category (64 FR 60194, November
4, 1999) (FRL–6097–7). Because of the
potential PBT nature of the PMN
substances, bioaccumulation and the
potential for eventual exposure to
humans and wildlife could result from
exposure to concentrations below 100
ppb. Therefore, to adequately mitigate
this concern, EPA has decided to limit
surface water concentrations resulting
from manufacturing, processing, or use
to 1 ppb or less for each of the PMN
substances.
Recommended testing: EPA has
determined that a fish bioconcentration
factor (BCF) test (OPPTS 850.1730 test
guideline (public draft)) would help
characterize the environmental effects of
the substances. The PMN submitter has
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agreed not to exceed the production
volume limit without performing the
fish BCF test on P–00–1122 or P–00–
1126. EPA has determined that a 90-day
inhalation toxicity study in rats with a
60-day holding period with special
attention to the histopathology of the
lungs (OPPTS 870.3465 test guideline)
would help characterize the human
health effects of the PMN substances.
Based on the results of the 90-day study,
a 2-year inhalation carcinogenicity test
(OPPTS 870.4200 test guideline) may be
warranted.
CFR citations: 40 CFR 721.10008 (P–00–
1121); 40 CFR 721.10009 (P–00–1122);
40 CFR 721.10010 (P–00–1123); 40 CFR
721.10011 (P–00–1124); 40 CFR
721.10012 (P–00–1125); and 40 CFR
721.10013 (P–00–1126).
PMN Number P–01–109
Chemical name: Halogenated naphthalic
anhydride (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a dye
intermediate. Based on toxicity data on
structurally similar chemicals, EPA
expects toxicity to aquatic organisms to
occur at concentrations as low as 20 ppb
of the PMN substance in surface waters.
As described in the PMN, the substance
is not released to surface waters.
Therefore, EPA has not determined that
the proposed processing or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
releases to surface waters may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of the
following testing would help
characterize the PMN substance: An
algal toxicity test (OPPTS 850.5400 test
guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test
guideline (public draft)), and a fish
acute toxicity test (OPPTS 850.1075 test
guideline (public draft)).
CFR citation: 40 CFR 721.10014.
PMN Number P–01–110
Chemical name: Halogenated
benzimidazole (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a dye
intermediate. Based on Structure
Activity Relationships (SAR) analysis,
EPA expects toxicity to aquatic
organisms to occur at concentrations as
low as 1 ppb of the PMN substance in
surface waters. In addition, EPA has
identified environmental concerns
because the PMN substance may be
persistent, bioaccumulative, and toxic
based on physical/chemical properties
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of the PMN substance, consistent with
the New Chemical Program’s PBT
Category (64 FR 60194, November 4,
1999). As described in the PMN, the
substance is not released to surface
waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance resulting in
release of the PMN substance to surface
waters may cause significant adverse
environmental effects, since the PMN
substance has been characterized by
EPA as a PBT. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of the
following tiered testing would help
characterize the PMN substance: Tier 1
- Melting point/melting range test
(OPPTS 830.7200 test guideline) and an
octanol water partition coefficient/Kow
test (OPPTS 830.7550 test guideline);
Tier 2 - Activated sludge sorption
isotherm (OPPTS 835.1110 test
guideline) or modified coagulationflocculation jar test of water (D2034–80);
Tier 3 - An algal toxicity test (OPPTS
850.5400 test guideline (public draft)), a
daphnid acute toxicity test (OPPTS
850.1010 test guideline (public draft))
and a fish acute toxicity test (OPPTS
850.1075 test guideline (public draft));
Tier 4 - tiered testing as described in the
New Chemicals Program’s PBT Category
(excluding the octanol water partition
coefficient/Kow test already
recommended in Tier 1).
CFR citation: 40 CFR 721.10015.
PMN Number P–01–111
Chemical name:
Dibenzimidazothianaphthalene
(generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a fluorescent
dye. Based on toxicity data on
structurally similar chemicals, EPA
expects chronic toxicity to aquatic
organisms to occur at concentrations as
low as 1 ppb of the PMN substance in
surface waters. As described in the
PMN, the substance is not released to
surface waters. Therefore, EPA has not
determined that the proposed
processing or use of the substance may
present an unreasonable risk. EPA has
determined, however, that releases to
surface waters may cause significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(ii).
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Recommended testing: EPA has
determined that the results of the
following tiered testing would help
characterize the PMN substance: Tier 1
- Activated sludge sorption isotherm test
(OPPTS 835.1110 test guideline) or
modified coagulation-flocculation jar
test of water (D2034–80); Tier 2 - An
algal toxicity test (OPPTS 850.5400 test
guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test
guideline (public draft)), and a fish
acute toxicity test (OPPTS 850.1075 test
guideline (public draft)); and Tier 3 - A
daphnid chronic toxicity test (OPPTS
850.1300 test guideline (public draft))
and a fish early-life stage toxicity test
(OPPTS 850.1400 test guideline (public
draft)).
CFR citation: 40 CFR 721.10016.
PMN Numbers P–01–257/258/259 and
P–01–261
Chemical name: Amine terminated
bisphenol A diglycidyl ether polymer
(generic).
CAS number: Not available.
Basis for action: The PMNs state that the
substances will be used as epoxy resin
curing agents. Based on analogy to
structurally similar polycationic
polymers, EPA is concerned that
toxicity to aquatic organisms may occur
at concentrations as low as 40 ppb in
surface waters. As described in the
PMNs, the substances are not released to
surface waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
other uses of the substances resulting in
release to surface waters may cause
significant adverse environmental
effects. Based on this information, the
PMN substances meet the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), a fish acute toxicity test (OPPTS
850.1075 test guideline (public draft)),
and a fish acute toxicity test mitigated
by humic acid (OPPTS 850.1085 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substances.
CFR citation: 40 CFR 721.10017.
PMN Number P–01–442
Chemical name: Calcium hydroxide
oxide silicate (Ca6(OH)2O2(Si2O5)3).
CAS number: 13169–90–9.
Basis for action: The PMN states that the
substance will be used as a filler to
reinforce resins, an additive for resins,
and a filter medium. Based on test data
on this chemical and structurally
similar compounds, EPA has identified
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human health concerns for cancer and
toxicity to the respiratory tract, lungs,
respiratory system, and liver to workers
exposed via inhalation. As described in
the PMN, significant worker exposure is
unlikely. Therefore, EPA has not
determined that the proposed import,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that domestic
manufacture, uses other than as
described in the PMN, or processing or
use as a powder resulting in significant
worker inhalation exposure may cause
significant adverse human health
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i),
and (b)(3)(ii).
Recommended testing: EPA has
determined that a 90-day inhalation
toxicity study (OPPTS 870.3465 test
guideline) would help characterize the
human health effects of the PMN
substance.
PMN Number P–01–564
Chemical name: Benzoic acid, 5-amino2-chloro-, 1,1-dimethyl-2-oxo-2-(2propenyloxy) ethyl ester.
CAS number: 174489–43–1.
Basis for action: The PMN states that the
substance will be used as a chemical
intermediate. Based on structural
analogy to anilines, EPA is concerned
that toxicity to aquatic organisms may
occur at concentrations as low as 1 ppb
of the PMN substance in surface waters.
As described in the PMN, the substance
is not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance resulting in release to
surface waters may cause significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.10018.
PMN Number P–01–563
Chemical name: Benzoic acid, 2-chloro5-nitro-, 1,1-dimethyl-2-oxo-2-(2propenyloxy) ethyl ester.
CAS number: 174489–76–0.
Basis for action: The PMN states that the
substance will be used as a chemical
intermediate. Based on submitted test
data and on structural analogy to esters,
EPA is concerned that toxicity to
aquatic organisms may occur at
concentrations as low as 3 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance resulting in release to
surface waters may cause significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at § 721.170
(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has
determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), an algal toxicity test (OPPTS
850.5400 test guideline (public draft)),
and an aerobic aquatic biodegradation
test with an analytical methodology to
identify the isononyl phenol
degradation product (OPPTS 835.3100
test guideline) would help characterize
the environmental effects of the PMN
substance.
Recommended testing: EPA has
determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), an algal toxicity test (OPPTS
850.5400 test guideline (public draft)),
and an aerobic aquatic biodegradation
test with an analytical methodology to
identify the isononyl phenol
degradation product (OPPTS 835.3100
test guideline) would help characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10019.
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CFR citation: 40 CFR 721.10020.
PMN Number P–01–764
Chemical name: Magnesium potassium
titanium oxide.
CAS number:39290–90–9.
Effective date of section 5(e) consent
order: July 29, 2002.
Basis for section 5(e) consent order: The
PMN states that the generic (nonconfidential) use of the substance will
be as a physical characteristics modifier
for industrial use in certain solid
composite articles. The order was issued
under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present
an unreasonable risk of injury to human
health. To protect against this risk, the
consent order requires worker
protection and hazard communication
and restricts the aggregate manufacture/
importation volume of the PMN
substance. The SNUR designates as a
‘significant new use’ the absence of
these protective measures.
Toxicity concern: Based on test data on
titanium dioxide, EPA has health
concerns for lung toxicity, including
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lung overload and oncogenicity, with
inhalation exposure. The NCEL is 5 mg/
m3 as an 8-hour time-weighted average.
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity study with a 60-day
holding period (OPPTS 870.3465 test
guideline) and possibly a 2-year
carcinogenicity study (OPPTS 870.4200
test guideline) would help characterize
the human health effects of the PMN
substance. The consent order contains
two production volume limits. The
PMN submitter agreed not to exceed the
first production volume limit without
performing the 90-day inhalation
toxicity study and not to exceed the
second production volume limit
without performing the 2-year
carcinogenicity study if warranted based
on the results of the first study.
CFR citation: 40 CFR 721.10021.
PMN Numbers P–01–769/770/771/772
Chemical names: (P–01–769)
Benzenamine, N-phenyl-, ar-(C9-rich
C8-10-branched alkyl) derivs; (P–01–770)
Benzenamine, N-phenyl-, ar, ar′-(C9-rich
C8-10-branched alkyl) derivs; (P–01–771)
10H-Phenothiazine, ar-(C9-rich C8-10branched alkyl) derivs; and (P–01–772)
10H-Phenothiazine, ar, ar′-(C9-rich C8-10branched alkyl) derivs.
CAS numbers: (P–01–769) 333955–69–
4, (P–01–770) 333955–70–7, (P–01–771)
333955–79–6, and (P–01–772) 333955–
80–9.
Basis for action: The PMNs state that the
substances will be used as antioxidants
for lubricating oils. EPA has identified
human health and environmental
concerns because the PMN substances
may be persistent, bioaccumulative, and
toxic, based on submitted test data and
physical/chemical properties of the
PMN substances, consistent with the
New Chemical Program’s PBT Category
(64 FR 60194, November 4, 1999). As
described in the PMNs, significant
worker exposure is unlikely and the
substances are not released to surface
waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
PMN substances may present an
unreasonable risk. EPA has determined,
however, that use of the PMN
substances other than as described in
the PMNs resulting in release to water
may cause serious chronic human
health effects and significant
environmental effects, since the PMN
substances have been characterized by
EPA as a PBT. Based on this
information, the PMN substances meet
the concern criteria at § 721.170 (b)(3)(i),
(b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of testing
Tiers 2 and 3 as described in the New
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Chemicals Program’s PBT Category
would help characterize the PBT
attributes of the PMN substances.
CFR citations: 40 CFR 721.10022 (P–01–
769); 40 CFR 721.10023 (P–01–770); 40
CFR 721.10024 (P–01–771); and 40 CFR
721.10025 (P–01–772).
PMN Number P–01–856
Chemical name: Cashew, nutshell liq.,
ethoxylated.
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CAS number: 350820–95–0.
Effective date of section 5(e) consent
order: July 5, 2002.
Basis for section 5(e) consent order: The
PMN states that the substance will be
used as a pigment dispersant. The order
was issued under section 5(e)(1)(A)(i)
and (e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present
an unreasonable risk of injury to the
environment. To protect against this
risk, the consent order restricts
molecular weight and composition of
the PMN substance. The SNUR
designates as a ‘significant new use’ the
absence of these protective measures.
Toxicity concern: Based on test data on
structurally similar nonionic
surfactants, particularly alkyl
ethoxylate, EPA has concerns that the
environmental toxicity of the PMN
substance varies depending on the
average number of moles of the ethoxy.
As the number of moles of ethoxy
decreases, the aquatic toxicity of the
substance increases. For this PMN
substance, the average number of moles
may vary. When the average number of
moles of the ethoxy group is 80, EPA
expects toxicity to aquatic organisms to
occur at concentrations as low as 1,000
ppb.
Recommended testing: The Agency has
determined that the results of a fish
acute toxicity test (OPPTS 850.1075 test
guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test
guideline (public draft)), and an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help
characterize possible environmental
effects of the substance. The tests
should be conducted on the PMN
substance with less than 55 moles of the
ethoxy group or with an average
molecular weight less than 2,700
daltons.
CFR citation: 40 CFR 721.10026.
PMN Number P–01–862
Chemical name: Ethoxylated
alkylsulfate, substituted alkylamine salt
(generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a processing aid.
Based on analogy to cationic surfactants
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and similar substances, EPA is
concerned that chronic toxicity to
aquatic organisms may occur at
concentrations as low as 4 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface waters in
significant quantities. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance resulting in
significant release to surface waters may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish early-life stage
toxicity test (OPPTS 850.1400 test
guideline (public draft)), a daphnid
chronic toxicity test (OPPTS 850.1300
test guideline (public draft)), and a
ready biodegradability test (OPPTS
835.3110 test guideline) would help
characterize the chronic environmental
effects and the fate in the environment
of the PMN substance. After this testing
is completed, if the results of the testing
and projected environmental risk
warrant it, a porous pot test (OPPTS
835.3220 test guideline) or modified
semi-continuous activated sludge
(SCAS) test (OPPTS 835.3210 test
guideline) would further characterize
the environmental fate of this substance.
CFR citation: 40 CFR 721.10027.
PMN Numbers P–01–901 and P–01–902
Chemical name: Disubstituted benzene
metal salt (generic).
CAS number: Not available.
Basis for action: The PMNs state that the
generic (non-confidential) use of the
substances will be as a polymer
additive. Based on test data and analogy
to phenols and hydroquinones/
quinones, EPA has concerns for dermal
corrosivity, acute toxicity, kidney and
liver effects, mutagenicity,
carcinogenicity, neurotoxicity,
developmental toxicity, depigmentation
of skin, thyroid effects, and
sensitization. Also, based on analogy to
phenols and hydroquinones/quinones,
EPA is concerned that toxicity to
aquatic organisms may occur at
concentrations as low as 1 ppb in
surface waters. As described in the
PMNs, significant worker exposure is
not expected as workers wear
impervious personal protective
equipment and significant
environmental exposure is not expected
as the substances are not released to
surface waters in significant quantities.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substances may
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present an unreasonable risk. EPA has
determined, however, that use of the
substances without workers wearing
impervious gloves or uses other than as
described in the PMNs could result in
serious health effects or significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at § 721.170
(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and
(b)(4)(ii).
Recommended testing: EPA has
determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)) would help characterize the
environmental effects of the PMN
substances. EPA has also determined
that a 90-day inhalation toxicity study
with a 60-day holding period (OPPTS
870.3465 test guideline) would help
characterize the human health effects.
CFR citation: 40 CFR 721.10028.
PMN Number P–01–918
Chemical name: Isocyanate compound,
modified with methoxysilane (generic).
CAS number: Not available.
Effective date of section 5(e) consent
order: May 30, 2002.
Basis for section 5(e) consent order: The
PMN states that the generic (nonconfidential) use of the substance will
be as a sealant. The order was issued
under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present
an unreasonable risk of injury to human
health. To protect against this risk, the
consent order requires worker
protection and hazard communication
and restricts the aggregate manufacture/
importation volume of the PMN
substance. The SNUR designates as a
‘significant new use’ the absence of
these protective measures.
Toxicity concern: Based on test data on
diisocyanates, the Agency has concern
for dermal and respiratory sensitization
and pulmonary toxicity. The NCEL is
0.05 mg/m3 or 0.005 ppm as an 8-hour
time-weighted average.
Recommended testing: EPA has
determined that the results of a skin
sensitization study (OPPTS 870.2600
test guideline) and a 90-day inhalation
toxicity study (OPPTS 870.3465 test
guideline) would help characterize the
human health effects of the substance.
CFR citation: 40 CFR 721.10029.
PMN Number P–01–919
Chemical name: Pyrimido[5,4g]pteridine-2,4,6,8-tetramine, 4methylbenzenesulfonate, basehydrolyzed.
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CAS number: 346709–25–9.
Basis for action: The PMN states that the
substance will be used as a pigment for
thermoplastic polymers. Based on
analogy to structurally similar Nheterocyclic chemicals, EPA has
concerns for potential developmental
toxicity from exposure to the PMN
material. Significant worker exposure is
unlikely when the substance is used as
described in the PMN. In addition,
based on test data on the PMN
substance, EPA is concerned that
chronic toxicity to aquatic organisms
may occur at concentrations as low as
10 ppb in surface waters. As described
in the PMN, the substance is not
released to surface waters in significant
quantities. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
domestic manufacture of the substance
may cause serious health effects and
significant environmental effects. Based
on this information, the PMN substance
meets the concern criteria at § 721.170
(b)(3)(ii) and (b)(4)(i).
Recommended testing: EPA has
determined that a combined repeated
dose toxicity study with the
reproduction/developmental toxicity
screening test (OPPTS 870.3650 test
guideline), a daphnid chronic toxicity
test (OPPTS 850.1300 test guideline
(public draft)), and a fish early-life stage
toxicity test (OPPTS 850.1400 test
guideline (public draft)) would help
characterize the human health and
environmental effects of the substance.
CFR citation: 40 CFR 721.10030.
PMN Number P–02–214
Chemical name: Lithium potassium
titanium oxide.
CAS number: 39318–30–4.
Effective date of section 5(e) consent
order: June 17, 2002.
Basis for section 5(e) consent order: The
PMN states that the generic (nonconfidential) use of the substance will
be as a physical characteristics modifier
for industrial use in certain solid
composite articles. The order was issued
under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present
an unreasonable risk of injury to human
health. To protect against this risk, the
consent order requires worker
protection and hazard communication
and restricts the aggregate manufacture/
importation volume of the PMN
substance. The SNUR designates as a
‘significant new use’ the absence of
these protective measures.
Toxicity concern: Based on test data on
titanium dioxide, the Agency has
concerns for lung toxicity (including
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oncogenicity) if the PMN substance is
inhaled. The NCEL is 5 mg/m3 as an 8hour time-weighted average.
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity study with a 60-day
holding period (OPPTS 870.3465 test
guideline) and possibly a 2-year
carcinogenicity study (OPPTS 870.4200
test guideline) would help characterize
the human health effects of the PMN
substance. The consent order contains
two production volume limits. The
PMN submitter agreed not to exceed the
first production volume limit without
performing the 90-day inhalation
toxicity study and not to exceed the
second production volume limit
without performing the 2-year
carcinogenicity study if warranted based
on the results of the first study.
CFR citation: 40 CFR 721.10031.
PMN Number P–02–269
Chemical name: Acrylic acid, polymer
with substituted acrylamides (generic).
CAS number: Not available.
Effective date of section 5(e) consent
order: October 22, 2002.
Basis for section 5(e) consent order: The
PMN states that the generic (nonconfidential) use of the substance will
be as a thermo-sensitive water
absorbing/desorbing polymer to soil.
The order was issued under section
5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA
based on a finding that this substance
may present an unreasonable risk of
injury to human health. To protect
against this risk, the consent order
restricts the particle size of the PMN
substance. The SNUR designates as a
‘significant new use’ the absence of this
protective measure.
Toxicity concern: Based on test data on
swellable high molecular weight
polymers (see 60 FR 16319–16320,
March 29, 1995) (FRl–4921–9), the
Agency has concerns for lung toxicity
and oncogenicity if the PMN substance
is inhaled.
Recommended testing: The Agency has
determined that a 90-day inhalation
toxicity study (OPPTS 870.3465 test
guideline) and a carcinogenicity study
(OPPTS 870.4200 test guideline) would
help characterize possible human health
effects of the substance.
CFR citation: 40 CFR 721.10032.
PMN Number P–02–322
Chemical name: Zinc, [ethanedioato(2-). kappa. O1, . kappa. O2]-.
CAS number: 547–68–2.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as an intermediate.
Based on analogy to similar zinc
compounds, EPA is concerned that
toxicity to aquatic organisms may occur
at concentrations above 1 ppb in surface
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waters. As described in the PMN,
releases of the substance are not
expected to result in surface water
concentrations above 1 ppb. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the PMN substance may cause
significant adverse effects. EPA has
determined, however, that other uses of
the PMN substance resulting in surface
water concentrations above 1 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)), a fish early-life
stage toxicity test (OPPTS 850.1400 test
guideline (public draft)), and a daphnid
chronic toxicity test (OPPTS 850.1300
test guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10033.
PMN Number P–02–359
Chemical name: Substituted pyridine
coupled with diazotized substituted
nitrobenzonitrile, diazotized substituted
benzenamine and substituted
pyridinecarbonitrile (generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a textile dye. Based
on structural analogy to neutral
organics, EPA is concerned that chronic
toxicity to aquatic organisms may occur
at concentrations above 1 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface waters in
significant quantities. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance resulting in
release to surface waters in
concentrations above 1 ppb may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish early-life toxicity
test (OPPTS 850.1400 test guideline
(public draft)), a daphnid chronic
toxicity test (OPPTS 850.1300 test
guideline (public draft)), and an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10034.
PMN Number P–02–382
Chemical name: Alkylbenzene sulfonate
(generic).
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CAS number: Not available.
Effective date of section 5(e) consent
order: December 17, 2002.
Basis for section 5(e) consent order: The
PMN states that the generic (nonconfidential) use of the substance will
be as a petroleum lubricant additive.
The order was issued under section
5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA
based on a finding that this substance
may present an unreasonable risk of
injury to the environment. To protect
against this risk, the consent order
restricts the formulation of the PMN
substance. The SNUR designates as a
‘significant new use’ the absence of this
protective measure. In addition, the
order was issued under section
5(e)(1)(A)(ii)(II) of TSCA based on a
finding that this substance will be
produced in substantial quantities and
may reasonably be anticipated to enter
the environment in substantial
quantities.
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Toxicity concern: Based on analogy to
structurally similar anionic surfactants,
EPA expects toxicity to aquatic
organisms to occur at concentrations as
low as 500 ppb in surface waters.
However, when the PMN substance is
manufactured, processed, and used in
mineral oil as described in the PMN,
EPA does not expect releases of this
PMN substance to pose a risk to the
environment. The oil diluent serves to
minimize dispersion and bioavailability
of the PMN substance in surface waters.
EPA has determined that other uses of
the substance when not diluted in
mineral oil may result in significant
release to surface waters and may cause
significant adverse environmental
effects.
Recommended testing: EPA has
determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)) would help characterize the
environmental effects of the PMN
substance when not used in mineral oil.
CFR citation: 40 CFR 721.10035.
PMN Number P–02–406
Chemical name: Acetaldehyde based
polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a corrosion
inhibitor. EPA has identified health and
environmental concerns for this
substance. EPA has identified health
concerns for carcinogenicity and dermal
sensitization based on analogy to
structurally similar chemicals. Based on
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structural analogy to aldehydes, EPA is
concerned that toxicity to aquatic
organisms may occur at concentrations
as low as 1 ppb of the PMN substance
in surface waters. In addition, the PMN
substance may be persistent,
bioaccumulative, and potentially toxic
based on physical/chemical properties
of the PMN substance as described in
the New Chemical Program’s PBT
Category (64 FR 60194, November 4,
1999). As described in the PMN,
significant worker exposure is unlikely
and the substance is not released to
surface waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
PMN substance may present an
unreasonable risk. EPA has determined,
however, that other domestic
manufacturing or other uses that result
in predictable or purposeful releases to
surface water could result in exposures
which may cause serious chronic
human health effects and significant
environmental effects since the
substance has been characterized by
EPA as a PBT. Based on this
information, the PMN substance meets
the concern criteria at § 721.170
(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of the tiered
testing as described in the New
Chemicals Program’s PBT Category
would help characterize the PBT
attributes of the PMN substance.
CFR citation: 40 CFR 721.10036.
PMN Number P–02–423
Chemical name: Complex halogenated
salt of tris(ethylated
aminocarbocyclic)methane (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a colorant for
inks. Based on structurally similar
compounds, EPA has identified human
health concerns for carcinogenicity,
mutagenicity, reproductive effects, and
developmental effects from inhalation
exposure to the PMN substance. In
addition, based on structurally similar
compounds, EPA expects toxicity to
aquatic organisms at surface water
concentrations above 1 ppb. As
described in the PMN, significant
worker and environmental exposure are
unlikely. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance resulting in
surface water concentrations above 1
ppb or any processing or use beyond the
site of manufacture or import could
result in worker and environmental
exposures which may cause
carcinogenic and serious chronic effects
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in humans and significant
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170
(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has
determined that a prenatal
developmental toxicity study by the oral
route (OPPTS 870.3700 test guideline),
a reproductive and fertility effects study
(OPPTS 870.3800 test guideline), a
Salmonella typhimurium reverse
mutation assay (40 CFR 798.5265), and
a mammalian erythrocyte micronucleus
study by the intraperitoneal route
(OPPTS 870.5395 test guideline) would
help characterize the human health
effects of the PMN substance. Positive
results in the mutagencity studies
would trigger a carcinogenicity study
(OPPTS 870.4200 test guideline). In
addition, EPA has determined that a fish
acute toxicity test (OPPTS 850.1075 test
guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test
guideline (public draft)), and an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10037.
PMN Number P–02–434
Chemical name: Trimellitic anhydride,
polymer with substituted glycol, alkyl
phenols and ethoxylated nonylphenol
(generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as curing resin
for industrial can coatings. Based on
structural analogy to esters, EPA is
concerned that toxicity to aquatic
organisms may occur at concentrations
as low as 1 ppb of the PMN substance
in surface waters. As described in the
PMN, the substance is not released to
surface waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance resulting in
release to surface waters may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that an aerobic
biodegradation test with an analytical
methodology to identify the branchednonyl phenol degradation product
(OPPTS 835.3100 test guideline) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10038.
PMN Number P–02–514
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Chemical name: Diethoxybenzenamine
derivative, diazotized, coupled with
aminonaphthalenesulfonic acid
derivative, ammonium salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a dyestuff in
printing ink. Based on structural
analogy, EPA has identified concerns for
carcinogenicity, mutagenicity, and
developmental toxicity for the
substituted beta-naphthylamine azo
reduction product, blood and
developmental toxicity for the anilineacid-based azo reduction product, and
carcinogenicity, developmental, liver
toxicity and sensitization for the paraphenylenediamine-based azo reduction
product. There is concern for chronic
effects based on the submitted 28-day
subchronic study with a No Observed
Adverse Effect Level (NOAEL) of 15 mg/
kg. As described in the PMN, worker
inhalation exposures are not expected.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that domestic
manufacture or processing or use of the
substance as a solid may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170
(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and
(b)(3)(iii).
Recommended testing: EPA has
determined that a prenatal
developmental toxicity study by the oral
route in two species (40 CFR 799.9370),
an Ames assay with the Prival
modification with a concurrent positive
control (OPPTS 870.5100 test
guideline), and a 90-day inhalation
toxicity study in rats (OPPTS 870.3465
test guideline) would help characterize
the human health effects of the PMN
substance.
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CFR citation: 40 CFR 721.10039.
PMN Number P–02–522
Chemical name: Substituted acridine
naphtha substituted benzamide
(generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be in exhaust dyeing of
polyester fibers. Based on analogy to
neutral organics, EPA is concerned that
toxicity to aquatic organisms may occur
at concentrations above 2 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations above 2
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ppb. Therefore, EPA has not determined
that the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance resulting in release to
surface waters in concentrations above 2
ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)), a fish chronic
toxicity test (OPPTS 850.1400 test
guideline (public draft)), and a daphnid
chronic toxicity test (OPPTS 850.1300
test guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10040.
PMN Number P–02–530
Chemical name: 1-Butanone, 2(dimethylamino)-2-[(4methylphenyl)methyl]-1-[4-(4morpholinyl)phenyl]-.
CAS number: 119344–86–4.
Basis for action: The PMN states that the
substance will be used as a photo
initiator for coatings and inks. Based on
structural analogy to aliphatic amines,
EPA is concerned that toxicity to
aquatic organisms may occur at
concentrations as low as 2 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface waters in
significant quantities. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
domestic manufacture of the PMN
substance may result in significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and an algal toxicity test (OPPTS
850.5400 test guideline (public draft))
would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10041.
PMN Number P–02–585
Chemical name: 2-Propanol, 1-[bis(2hydroxyethyl)amino]-.
CAS number: 6712–98–7.
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Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a grinding aid and
intermediate. EPA has identified health
concerns for lung sensitization and
carcinogenicity based on analogy to
triethanolamine. There is concern for
developmental toxicity, eye irritation,
liver toxicity, kidney toxicity, and blood
toxicity based on submitted test data. As
described in the PMN, significant
inhalation exposure is unlikely.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance other than as described in
the PMN may result in significant
human exposure. Based on this
information, the PMN substance meets
the concern criteria at § 721.170
(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has
determined that a prenatal
developmental toxicity study by the oral
route in rats (OPPTS 870.3700 test
guideline) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10042.
PMN Number P–02–697
Chemical name: Dineopentyl-4substituted phthalate (generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a catalyst
component. EPA has identified health
and environmental concerns because
the PMN substance may be persistent,
bioaccumulative, and toxic based on
physical/chemical properties of the
PMN substance as described in the New
Chemical Program’s PBT Category (64
FR 60194, November 4, 1999). EPA has
identified health concerns for
developmental toxicity based on
analogy to other phthalates and
concerns for liver, kidney, and
neurotoxicity based on analogy to
haloaromatic compounds. As described
in the PMN, significant worker exposure
is unlikely and the substance is not
released to surface waters. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the PMN substance may present
an unreasonable risk. EPA has
determined, however, that other uses of
the PMN substance which may result in
predictable or purposeful release of the
PMN substance into waters of the
United States or any use of the PMN
substance other than as described in the
PMN could result in exposures which
may cause serious chronic human
health effects and significant
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environmental effects since the PMN
substance has been characterized by
EPA as a PBT. Based on this
information, the PMN substance meets
the concern criteria at § 721.170
(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of the tiered
testing as described in the New
Chemicals Program’s PBT Category
would help characterize the PBT
attributes of the PMN substance.
CFR citation: 40 CFR 721.10043.
PMN Number P–02–698
Chemical name: Metal oxide, modified
with alkyl and vinyl terminated
polysiloxanes (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as an adhesive.
EPA has identified health concerns for
lung toxicity based on analogy to poorly
soluble respirable particulates. As
described in the PMN, significant
worker exposure is unlikely. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substance may present an
unreasonable risk. EPA has determined,
however, that manufacturing,
processing, or use of the substance as a
powder could result in exposures which
may cause serious health effects. Based
on this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(ii).
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Recommended testing: EPA has
determined that a 90-day inhalation
toxicity study in rodents with a 60-day
holding period (OPPTS 870.3465 test
guideline) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10044.
PMN Number P–02–737
Chemical name: Diazotized substituted
heteromonocycle coupled with
naphthalene sulfonic acid derivative,
nickel complex, alkaline salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a colorant for
coating compositions. EPA has
identified concerns for carcinogenicity,
pulmonary sensitization,
immunotoxicity, developmental
toxicity, and neurotoxicity from
analogous compounds, and
carcinogenicity, mutagenicity, and
developmental toxicity for the azo
reduction products. As described in the
PMN, worker inhalation exposure is not
expected. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
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risk. EPA has determined, however, that
domestic manufacture or processing or
use of the substance as a solid may
cause serious health effects. Based on
this information, the PMN substance
meets the concern criteria at § 721.170
(b)(1)(i)(C), (b)(1)(i)(D), (b)(3)(ii), and
(b)(3)(iii).
Recommended testing: EPA has
determined that a 90-day oral toxicity
test in rodents (OPPTS 870.3100 test
guideline), a bacterial reverse mutation
test with Prival modification (OPPTS
870.5100 test guideline), and an
unscheduled DNA synthesis test in rat
hepatocytes (OPPTS 870.5550 test
guideline) would help characterize the
human health effects of the PMN
substance. If warranted by the results of
any of the three above studies, a
carcinogenicity test (OPPTS 870.4200
test guideline) is recommended.
CFR citation: 40 CFR 721.10045.
PMN Number P–02–747
Chemical name: Polyaromatic amine
phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a film
additive. Based on structural analogy to
soluble nonionic dyes and inorganic
phosphates, EPA is concerned that
toxicity to aquatic organisms may occur
at concentrations as low as 10 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance resulting in release to
surface waters may cause significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and an algal toxicity test (OPPTS
850.5400 test guideline (public draft))
would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10046.
PMN Number P–02–766
Chemical name: Polyphosphoric acids,
compds. with piperazine.
CAS number: 383905–85–9.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a flame retardant.
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Based on analogy to aliphatic amines
and inorganic phosphates, EPA is
concerned that toxicity to aquatic
organisms may occur at concentrations
as low as 10 ppb of the PMN substance
in surface waters. As described in the
PMN, the substance is not released to
surface waters in significant quantities.
Therefore, EPA has not determined that
the proposed manufacturing or use of
the substance may present an
unreasonable risk. EPA has determined,
however, that use of the substance other
than as described in the PMN could
result in exposures which may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10047.
PMN Number P–02–869
Chemical name: Substituted
anthraquinone (generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as a site limited
intermediate. Based on structural
analogy to phenols, EPA is concerned
that chronic toxicity to aquatic
organisms may occur at concentrations
above 1 ppb of the PMN substance in
surface waters. As described in the
PMN, releases of the substance are not
expected to result in surface water
concentrations above 1 ppb. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substance may present an
unreasonable risk. EPA has determined,
however, that a manufacture/
importation volume greater than 4,500
kilograms/year may result in significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish early life stage
test (OPPTS 850.1400 test guideline
(public draft)), a daphnid chronic
toxicity test (OPPTS 850.1300 test
guideline (public draft)), and an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10048.
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PMN Number P–02–912
Chemical name: Phenol, 4,4′cyclohexylidenebis[2-methyl-.
CAS number: 2362–14–3.
Basis for action: The PMN states that the
substance will be used as a raw
material. Based on structural analogy to
phenols, EPA is concerned that chronic
toxicity to aquatic organisms may occur
at concentrations as low as 1 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface water. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substance may present an
unreasonable risk. EPA has determined,
however, that any release of the PMN
substance to surface water may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish early-life stage
toxicity test (OPPTS 850.1400 test
guideline (public draft)) and a daphnid
chronic toxicity test (OPPTS 850.1300
test guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10049.
PMN Number P–02–929
Chemical name: Disubstituted-N′hydroxy-benzenecarboximidamide
(generic).
CAS number: Not available.
Basis for action: The PMN states that the
substance will be used as an
intermediate. EPA has concerns for
chronic toxicity to blood, kidney, and
liver based on a submitted 28-day study.
As described in the PMN, significant
worker exposure is unlikely. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substance may present an
unreasonable risk. EPA determined,
however, that use of the substance other
than as an intermediate may result in
exposures which may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has
determined that a 90-day oral toxicity
study in rodents by the gavage route
(OPPTS 870.3100 test guideline) would
help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10050.
PMN Number P–02–961
Chemical name: Spiro naphthoxazine
(generic)
.
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
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substance will be as a colorant. Based
on structural analogy to neutral organic
chemicals, EPA expects chronic toxicity
to aquatic organisms at concentrations
as low as 1 ppb of the PMN substance
in surface waters. As described in the
PMN, the substance is not released to
surface waters in significant quantities.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that domestic
manufacture of the substance could
result in exposures which may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that a fish early-life stage
toxicity test (OPPTS 850.1400 test
guideline (public draft)) and a daphnid
chronic toxicity test (OPPTS 850.1300
test guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10051.
PMN Number P–02–1088
Chemical name: Aminoalkyl substituted
alkylphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be in a destructive use.
Based on structural analogy to phenols
and aliphatic amines, EPA is concerned
that toxicity to aquatic organisms may
occur at concentrations as low as 1 ppb
of the PMN substance in surface waters.
As described in the PMN, the substance
is not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing or use of
the substance may present an
unreasonable risk. EPA has determined,
however, that use of the substance other
than as described in the PMN could
result in exposures which may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), and a fish acute toxicity test
(OPPTS 850.1075 test guideline (public
draft)) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10052.
PMN Number P–03–41
Chemical name: Alkyl silane
methacrylate (generic).
CAS number: Not available.
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Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as a chemical
intermediate. Based on structural
analogy to methacrylates and esters,
EPA is concerned that toxicity to
aquatic organisms may occur at
concentrations as low as 3 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance resulting in release to
surface waters may cause significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test (OPPTS 850.1075 test
guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test
guideline (public draft)), and an algal
toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10053.
PMN Number P–03–43
Chemical name: Phenol, polymer with
formaldehyde, 3-[(2aminocyclohexyl)amino]-2hydroxypropyl ethers.
CAS number: 452082–53–0.
Basis for action:The PMN states that the
generic (non-confidential) use of the
substance will be as a resin component.
Based on structural analogy to
polycationic polymers, EPA is
concerned that toxicity to aquatic
organisms may occur at concentrations
as low as 20 ppb of the PMN substance
in surface waters. As described in the
PMN, the substance is not released to
surface waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance resulting in
release to surface waters may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public
draft)), a daphnid acute toxicity test
(OPPTS 850.1010 test guideline (public
draft)), a fish acute toxicity test (OPPTS
850.1075 test guideline (public draft)),
and a fish acute toxicity test mitigated
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by humic acid (OPPTS 850.1085 test
guideline (public draft)) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10054.
PMN Number P–03–46
Chemical name: 1-Propanaminium, 3amino-N-(carboxymethyl)-N,Ndimethyl-, N-soya acyl derivs., inner
salts.
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CAS number: 136504–87–5.
Basis for action: The PMN states that the
generic (non-confidential) use of the
substance will be as an oilfield foamer.
EPA has identified health concerns for
developmental toxicity, neurotoxicity,
irritation and corrosion to skin and eyes,
and lung effects based on analogy to
similar quaternary compounds. As
described in the PMN, significant
inhalation exposure is unlikely.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that other uses of
the substance other than as described in
the PMN may result in significant
human exposure. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that a prenatal
developmental toxicity study by the oral
route in rats or rabbits (OPPTS 870.3700
test guideline) and a repeated dose 28day oral toxicity study in rats (OPPTS
870.3050 test guideline) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10055.
PMN Number P–03–47
Chemical name:
Benzenemethanaminium, N-(3aminopropyl)-N,N-dimethyl-, N-soya
acyl derivs., chlorides.
CAS number: 90194–13–1.
Basis for action: The PMN states that the
generic (non-confidential) use of
substance will be as an oilfield
corrosion inhibitor. EPA has identified
health concerns for developmental
toxicity, neurotoxicity, lung effects,
irritation to the lungs and mucous
membranes, and severe eye irritation
based on analogy to similar quaternary
compounds. As described in the PMN,
significant inhalation exposure is
unlikely. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
other uses of the substance other than as
described in the PMN may result in
significant human exposure. Based on
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this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that a prenatal
developmental toxicity study by the oral
route in rats or rabbits (OPPTS 870.3700
test guideline) and a repeated dose 28day oral toxicity study in rats (OPPTS
870.3050 test guideline) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10056.
IV. Objectives and Rationale for this
Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs, EPA concluded
that for 13 of the 65 chemical
substances, regulation was warranted
under section 5(e) of TSCA, pending the
development of information sufficient to
make reasoned evaluations of the health
or environmental effects of the chemical
substances. The basis for such findings
is outlined in Unit III. Based on these
findings, TSCA section 5(e) consent
orders requiring the use of appropriate
exposure controls were negotiated with
the PMN submitters; the SNUR
provisions for these chemical
substances listed in this document are
consistent with the provisions of the
TSCA section 5(e) consent orders.
In the other 52 cases for which the
proposed uses are not regulated under a
TSCA section 5(e) consent order, EPA
determined that one or more of the
criteria of concern established at 40 CFR
721.170 were met, as discussed in Unit
III.
B. Objectives
EPA is issuing these SNURs for
specific chemical substances which
have undergone premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses designated in
this rule:
1. EPA will receive notice of any
person’s intent to manufacture, import,
or process a listed chemical substance
for the described significant new use
before that activity begins.
2. EPA will have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing, or
processing a listed chemical substance
for the described significant new use.
3. EPA will be able to regulate
prospective manufacturers, importers,
or processors of a listed chemical
substance before the described
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significant new use of the chemical
substance occurs, provided that
regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6 or 7.
4. EPA will ensure that all
manufacturers, importers, and
processors of the same chemical
substance that is subject to a TSCA
section 5(e) consent order are subject to
similar requirements.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Inventory. Manufacturers,
importers, and processors are
responsible for ensuring that a new
chemical substance subject to a final
SNUR is listed on the TSCA Inventory.
V. Direct Final Procedures
EPA is issuing these SNURs as a
direct final rule, as described in 40 CFR
721.160(c)(3) and 721.170(d)(4). In
accordance with 40 CFR
721.160(c)(3)(ii) and 721.170(d)(4)(i),
this rule will be effective May 29, 2007,
unless EPA receives a written notice by
April 30, 2007 of adverse or critical
comments, or notice of intent to submit
adverse or critical comments, on EPA’s
action. If EPA receives such a notice,
EPA will publish a document to
withdraw the direct final SNUR for the
specific chemical substance to which
the adverse or critical comments apply.
EPA will then propose a SNUR for the
specific chemical substance providing a
30-day comment period.
This action establishes SNURs for a
number of chemical substances. Any
person who submits adverse or critical
comments or notice of intent to submit
adverse or critical comments, must
identify the chemical substance and the
new use to which it applies. EPA will
not withdraw a SNUR for a chemical
substance not identified in a notice.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. Persons are required only to
submit test data in their possession or
control and to describe any other data
known to or reasonably ascertainable by
them. However, upon review of PMNs
and SNUNs, the Agency has the
authority to require appropriate testing.
In cases where EPA issued a TSCA
section 5(e) consent order that requires
or recommends certain testing, Unit III.
lists those tests. Unit III. also lists
recommended testing for non-5(e)
SNURs. Descriptions of recommended
tests are provided for informational
purposes. EPA strongly encourages
persons, before performing any testing,
to consult with the Agency pertaining to
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protocol selection. Many test guidelines
are now available on the Internet at
https://www.epa.gov/opptsfrs/home/
guidelin.htm.
In the TSCA section 5(e) consent
orders for several of the chemical
substances regulated under this rule,
EPA has established production limits
in view of the lack of data on the
potential health and environmental
risks that may be posed by the
significant new uses or increased
exposure to the chemical substances.
These production limits cannot be
exceeded unless the PMN submitter first
submits the results of toxicity tests that
would permit a reasoned evaluation of
the potential risks posed by these
chemical substances. Under recent
consent orders, each PMN submitter is
required to submit each study at least 14
weeks (earlier consent orders required
submissions at least 12 weeks) before
reaching the specified production limit.
Listings of the tests specified in the
TSCA section 5(e) consent orders are
included in Unit III. The SNURs contain
the same production volume limits as
the consent orders. Exceeding these
production limits is defined as a
significant new use. Persons who intend
to exceed the production limit must
notify the Agency by submitting a
SNUN at least 90 days in advance.
The recommended tests may not be
the only means of addressing the
potential risks of the chemical
substance. However, SNUNs submitted
for significant new uses without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
a prior submitter. EPA recommends that
potential SNUN submitters contact EPA
early enough so that they will be able
to conduct the appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
1. Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
2. Potential benefits of the chemical
substances.
3. Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
VII. Procedural Determinations
EPA is establishing through this rule
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2. EPA is required to keep this
information confidential to protect the
CBI of the original PMN submitter. EPA
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promulgated a procedure to deal with
the situation where a specific significant
new use is CBI. This procedure appears
in 40 CFR 721.1725(b)(1) and is similar
to that in § 721.11 for situations where
the chemical identity of the chemical
substance subject to a SNUR is CBI. This
procedure is cross-referenced in each of
the SNURs that include specific
significant new uses that are CBI.
A manufacturer or importer may
request EPA to determine whether a
proposed use would be a significant
new use under this rule. Under the
procedure in § 721.1725(b)(1), a
manufacturer or importer must show
that it has a bona fide intent to
manufacture or import the chemical
substance and must identify the specific
use for which it intends to manufacture
or import the chemical substance. If
EPA concludes that the person has
shown a bona fide intent to manufacture
or import the chemical substance, EPA
will tell the person whether the use
identified in the bona fide submission
would be a significant new use under
the rule. Since most of the chemical
identities of the chemical substances
subject to these SNURs are also CBI,
manufacturers and processors can
combine the bona fide submission
under the procedure in § 721.1725(b)(1)
with that under § 721.11 into a single
step.
If a manufacturer or importer is told
that the production volume identified in
the bona fide submission would not be
a significant new use, i.e., it is below the
level that would be a significant new
use, that person can manufacture or
import the chemical substance as long
as the aggregate amount does not exceed
that identified in the bona fide
submission to EPA. If the person later
intends to exceed that volume, a new
bona fide submission would be
necessary to determine whether that
higher volume would be a significant
new use. EPA is considering whether to
adopt a special procedure for use when
CBI production volume is designated as
a significant new use. Under such a
procedure, a person showing a bona fide
intent to manufacture or import the
chemical substance, under the
procedure described in § 721.11, would
automatically be informed of the
production volume that would be a
significant new use. Thus, the person
would not have to make multiple bona
fide submissions to EPA for the same
chemical substance to remain in
compliance with the SNUR, as could be
the case under the procedures in
§ 721.1725(b)(1).
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VIII. Applicability of Rule to Uses
Occurring Before Effective Date of the
Final Rule
To establish a significant ‘‘new’’ use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this rule have recently
undergone premanufacture review.
TSCA section 5(e) consent orders have
been issued for 13 chemical substances
and notice submitters are prohibited by
the TSCA section 5(e) consent orders
from undertaking activities which EPA
is designating as significant new uses. In
cases where EPA has not received a
notice of commencement (NOC) and the
chemical substance has not been added
to the TSCA Inventory, no other person
may commence such activities without
first submitting a PMN. For chemical
substances for which an NOC has not
been submitted at this time, EPA has
concluded that the uses are not ongoing.
However, EPA recognizes in cases when
chemical substances identified in this
SNUR are added to the TSCA Inventory
prior to the effective date of the rule, the
chemical substances may be
manufactured, imported, or processed
by other persons for a significant new
use as defined in this rule before the
effective date of the rule. However, 35
of the 65 chemical substances contained
in this rule have CBI chemical
identities, and since EPA has received a
limited number of post-PMN bona fide
submissions (per 40 CFR 720.25 and
721.11), the Agency believes that it is
highly unlikely that any of the
significant new uses described in the
following regulatory text are ongoing.
EPA solicits comments on whether any
of the uses described as significant new
uses are ongoing.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of section
5(a)(1)(B) of TSCA is best served by
designating a use as a significant new
use as of the date of publication of this
direct final rule rather than as of the
effective date of the rule. If uses begun
after publication were considered
ongoing rather than new, it would be
difficult for EPA to establish SNUR
notice requirements because a person
could defeat the SNUR by initiating the
significant new use before the rule
became final, and then argue that the
use was ongoing as of the effective date
of the final rule. Thus, persons who
begin commercial manufacture, import,
or processing of the chemical substances
regulated through this SNUR will have
to cease any such activity before the
effective date of this rule. To resume
their activities, these persons would
have to comply with all applicable
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SNUR notice requirements and wait
until the notice review period,
including all extensions, expires. EPA
has promulgated provisions to allow
persons to comply with this SNUR
before the effective date. If a person
were to meet the conditions of advance
compliance under § 721.45(h), the
person would be considered to have met
the requirements of the final SNUR for
those activities.
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IX. SNUN Submissions
EPA recommends that submitters
consult with the Agency prior to
submitting a SNUN to discuss what data
may be useful in evaluating a significant
new use. Discussions with the Agency
prior to submission can afford
submitters ample time to conduct any
tests that might be helpful in evaluating
risks posed by the substance. According
to 40 CFR 721.1(c), persons submitting
a SNUN must comply with the same
notice requirements and EPA regulatory
procedures as persons submitting a
PMN, including submission of test data
on health and environmental effects as
described in 40 CFR 720.50.
SNUNs must be mailed to the
Environmental Protection Agency,
OPPT Document Control Office
(7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
Information must be submitted in the
form and manner set forth in EPA Form
No. 7710–25. This form is available
from the Environmental Assistance
Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460–0001
(see 40 CFR 721.25 and 720.40). Forms
and information are also available
electronically at https://www.epa.gov/
opptintr/newchems/pubs/
pmnforms.htm.
X. Notification on Substances for Which
Significant New Use Rules are Not
Being Issued
As required in 40 CFR 721.160(a)(2),
EPA is providing notification on the
following two chemical substances that
are subject to final TSCA section 5(e)
consent orders but for which EPA has
decided not to issue significant new use
rules at this time. EPA is not publishing
SNURs for PMNs P–02–193 and P–03–
394 because they are subject to
exposure-based consent orders. EPA’s
exposure-based policies for new
chemical substances are based on TSCA
section 5(e)(1)(A)(ii)(II) and are
described on the New Chemicals
website at https://www.epa.gov/oppt/
newchems/pubs/expbased.htm.
Exposure-based consent orders are
based on two findings: 1) Insufficient
information available on the health and
environmental effects of the PMN
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substance, and 2) expected substantial
production volume and significant or
substantial human exposure and/or
release to the environment. Exposurebased consent orders prohibit the
submitter from exceeding a specific,
aggregate production or import volume
unless the submitter has conducted the
fate, aquatic toxicity, and/or health
effects testing specified in the order and
submitted the results to EPA. The
production or import volume limit is
usually set so that it will occur within
a few years. Therefore, instead of
publishing and often revoking exposurebased SNURs within a short timespan,
EPA generally defers publication of
SNURs on substances subject to
exposure-based consent orders until the
test data are received. In many cases,
data received through an exposurebased consent order confirm the
Agency’s prediction of low or no risk, so
no further regulatory action is
warranted.
XI. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substances
subject to this rule. EPA’s complete
economic analysis is available in the
public docket.
XII. Statutory and Executive Order
Reviews
1. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
the Office of Management and Budget
(OMB) has determined that a proposed
or final SNUR is not a ‘‘significant
regulatory action’’ subject to review by
OMB, because it does not meet the
criteria in section 3(f) of the Executive
order.
2. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under the
PRA, unless it has been approved by
OMB and displays a currently valid
OMB control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection
requirements related to this action have
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already been approved by OMB
pursuant to the PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
3. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
will not have a significant adverse
economic impact on a substantial
number of small entities. The rationale
supporting this conclusion is as follows.
A SNUR applies to any person
(including small or large entities) who
intends to engage in any activity
described in the rule as a ‘‘significant
new use.’’ By definition of the word
‘‘new,’’ and based on all information
currently available to EPA, it appears
that no small or large entities presently
engage in such activity. Since a SNUR
only requires that any person who
intends to engage in such activity in the
future must first notify EPA by
submitting a SNUN, no economic
impact will even occur until someone
decides to engage in those activities.
Although some small entities may
decide to conduct such activities in the
future, EPA cannot presently determine
how many, if any, there may be.
However, EPA’s experience to date is
that, in response to the promulgation of
over 1,000 SNURs, the Agency receives
on average only 10 notices per year. Of
those SNUNs submitted, none appear to
be from small entities in response to any
SNUR. In addition, the estimated
reporting cost for submission of a SNUN
(see Unit IX.), is minimal regardless of
the size of the firm. Therefore, EPA
believes that the potential economic
impact of complying with this SNUR is
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not expected to be significant or
adversely impact a substantial number
of small entities. In a SNUR that
published on June 2, 1997 (62 FR 29684)
(FRL–5597–1), the Agency presented it’s
general determination that proposed
and final SNURs are not expected to
have a significant economic impact on
a substantial number of small entities,
which was provided to the Chief
Counsel for Advocacy of the Small
Business Administration.
4. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reason to
believe that any State, local, or Tribal
government will be impacted by this
rulemaking. As such, EPA has
determined that this regulatory action
does not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any affect on small
governments subject to the requirements
of sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
8. Executive Order 13211: Actions that
Significantly Affect Energy Supply,
Distribution, or Use
This rule is not subject to Executive
Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use.
9. National Technology Transfer
Advancement Act
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
10. Executive Order 12898: Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
6. Executive Order 13175: Consultation
and Coordination with Indian Tribal
Governments
This rule does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This does not
significantly or uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000), do not apply
to this rule.
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5. Executive Order 13132: Federalism
This action will not have a substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999).
EPA has complied with Executive
Order 12630, entitled Governmental
Actions and Interference with
Constitutionally Protected Property
Rights (53 FR 8859, March 15, 1988), by
examining the takings implications of
this rule in accordance with the
‘‘Attorney General’s Supplemental
Guidelines for the Evaluation of Risk
and Avoidance of Unanticipated
Takings’’ issued under the Executive
order.
7. Executive Order 13045: Protection of
Children from Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
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11. Executive Order 12630:
Governmental Actions and Interference
with Constitutionally Protected Property
Rights (Takings)
12. Executive Order 12988: Civil Justice
Reform
In issuing this rule, EPA has taken the
necessary steps to eliminate drafting
errors and ambiguity, minimize
potential litigation, and provide a clear
legal standard for affected conduct, as
required by section 3 of Executive Order
12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).
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14697
13. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a final rule may take effect,
the Agency promulgating the final rule
must submit a final rule report to each
House of the Congress and to the
Comptroller General of the United
States. EPA will submit a report
containing this final rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: March 22, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is
amended as follows:
I
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
I
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. By adding new § 721.10002 to
subpart E to read as follows:
I
§ 721.10002
2-Thiazolidinone.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-thiazolidinone (PMN P–97–415; CAS
No. 2682–49–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1), (a)(3), (a)(4), (a)(6)(i), (b), and (c).
The following National Institute for
Occupational Safety and Health
(NIOSH)-approved respirators with an
assigned protection factor (APF) of 10–
25 meet the minimum requirements for
§ 721.63(a)(4): Air-purifying, tight-fitting
respirator (either half- or full-face)
equipped with N100 (if aerosols absent),
R100, or P100 filters; powered airpurifying respirator equipped with a
loose-fitting hood or helmet and High
Efficiency Particulate Air (HEPA) filters;
powered air-purifying respirator
equipped with a tight-fitting facepiece
(either half- or full-face) and HEPA
filters; and supplied-air respirator
operated in pressure demand or
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continuous flow mode and equipped
with a hood or helmet or tight-fitting
facepiece (either half- or full-face). As
an alternative to the respiratory
requirements listed here, a
manufacturer, importer, or processor
may choose to follow the new chemical
exposure limit (NCEL) provisions listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.7 mg/
m3 as an 8-hour time-weighted average.
Persons who wish to pursue NCELs as
an alternative to the § 721.63 respirator
requirements may request to do so
under 40 CFR 721.30. Persons whose
§ 721.30 requests to use the NCELs
approach are approved by EPA will
receive NCELs provisions comparable to
those contained in the corresponding
section 5(e) consent order.
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
1.0 percent), (f), (g)(1)(iii), (g)(1)(iv),
(g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv) (use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.7 mg/
m3), (g)(2)(v), (g)(3)(ii), (g)(4)(i), (g)(4)(ii),
(g)(4)(iii), and (g)(5). The following
statement shall appear on each label as
specified in § 721.72(b) and the Material
Safety Data Sheet (MSDS) as specified
in § 721.72(c). The substance may cause
severe eye irritation. The substance may
cause internal organ effects (blood, liver,
and kidney). The substance may cause
developmental/maternal effects. When
handling this substance as a powder,
use respiratory protection.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (g), (p) (300,000
kilograms), (v)(1), (w)(1), and (x)(1).
(iv) Disposal. Requirements as
specified in § 721.85 (a)(1), (a)(2), (a)(3),
(b)(1), (b)(2), (b)(3), (c)(1), (c)(2), and
(c)(3).
(v) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (e), (f), (g), (h), (i), (j), and
(k) are applicable to manufacturers,
importers, and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 3. By adding new § 721.10003 to
subpart E to read as follows:
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§ 721.10003 Manganese heterocyclic
tetraamine complex (generic).
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as manganese heterocyclic
tetraamine complex (PMNs P–98–625/
626/627/628/629 and P–00–614/617) are
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(s) (10,000
kilograms per chemical substance).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 4. By adding new § 721.10004 to
subpart E to read as follows:
§ 721.10004 2-Butenoic acid, 4,4′[(dibutylstannylene)bis(oxy)]bis[4-oxo-,
(2Z,2′Z)-, di-C8-10-isoalkyl esters, C9-rich.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-butenoic acid, 4,4′[(dibutylstannylene)bis(oxy)]bis[4-oxo-,
(2Z,2′Z)-, di-C8-10-isoalkyl esters, C9-rich
(PMN P–98–1181; CAS No. 247041–56–
1) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1), (a)(2)(i), and (a)(3).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (v)(2), (w)(2),
(x)(2), and (y)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (e), and (i) are applicable
to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 5. By adding new § 721.10005 to
subpart E to read as follows:
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§ 721.10005 2-Butenoic acid, 4,4′[(dibutylstannylene)bis(oxy)]bis [4-oxo-,
(2Z,2′Z)-, di-C9-11-isoalkyl esters, C10-rich.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-butenoic acid, 4 ,4′[(dibutylstannylene)bis(oxy)]bis [4-oxo-,
(2Z,2′Z)-, di-C9-11-isoalkyl esters, C10rich (PMN P–98–1182) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1), (a)(2)(i), and (a)(3).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (v)(2), (w)(2),
(x)(2), and (y)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (e), and (i) are applicable
to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 6. By adding new § 721.10006 to
subpart E to read as follows:
§ 721.10006
Mixed metal oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as mixed metal oxide (PMN
P–99–511) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(s) (60,000
kilograms).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 7. By adding new § 721.10007 to
subpart E to read as follows:
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§ 721.10007 Alcohols, C12-14- secondary,
ethoxylated propoxylated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
alcohols, C12-14- secondary, ethoxylated
propoxylated (PMN P–00–11; CAS No.
103331–86–8) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N = 50).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 8. By adding new § 721.10008 to
subpart E to read as follows:
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§ 721.10008
(MnSrO3).
Manganese strontium oxide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
manganese strontium oxide (MnSrO3)
(PMN P–00–1121; CAS No. 12163–45–0)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), (g)(1)(i), (g)(1)(ii),
(g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture,
processing, or use of the PMN substance
if the particle size is less than 10
microns) and (q).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 9. By adding new § 721.10009 to
subpart E to read as follows:
§ 721.10009
(MnYO3).
Manganese yttrium oxide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
manganese yttrium oxide (MnYO3)
(PMN P–00–1122; CAS No. 12032–75–6)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), (g)(1)(i), (g)(1)(ii),
(g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture,
processing, or use of the PMN substance
if the particle size is less than 10
microns) and (q).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 10. By adding new § 721.10010 to
subpart E to read as follows:
§ 721.10010
(BaMnO3).
Barium manganese oxide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
barium manganese oxide (BaMnO3)
(PMN P–00–1123; CAS No. 12230–80–7)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), (g)(1)(i), (g)(1)(ii),
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14699
(g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture,
processing, or use of the PMN substance
if the particle size is less than 10
microns) and (q).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 11. By adding new § 721.10011 to
subpart E to read as follows:
§ 721.10011 Barium calcium manganese
strontium oxide.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
barium calcium manganese strontium
oxide (PMN P–00–1124; CAS No.
359427–90–0) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), (g)(1)(i), (g)(1)(ii),
(g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture,
processing, or use of the PMN substance
if the particle size is less than 10
microns) and (q).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 12. By adding new § 721.10012 to
subpart E to read as follows:
§ 721.10012
(2:1).
Manganate (MnO21-), calcium
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
manganate (MnO21-), calcium (2:1)
(PMN P–00–1125; CAS No. 12049–47–7)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), (g)(1)(i), (g)(1)(ii),
(g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture,
processing, or use of the PMN substance
if the particle size is less than 10
microns) and (q).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 13. By adding new § 721.10013 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10013
(Mn2YO5).
Manganese yttrium oxide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
manganese yttrium oxide (Mn2YO5)
(PMN P–00–1126; CAS No. 12438–71–0)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), (g)(1)(i), (g)(1)(ii),
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(g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture,
processing, or use of the PMN substance
if the particle size is less than 10
microns) and (q).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 14. By adding new § 721.10014 to
subpart E to read as follows:
§ 721.10014 Halogenated naphthalic
anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated naphthalic
anhydride (PMN P–01–109) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 15. By adding new § 721.10015 to
subpart E to read as follows:
§ 721.10015
(generic).
Halogenated benzimidazole
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated
benzimidazole (PMN P–01–110) is
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subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 16. By adding new § 721.10016 to
subpart E to read as follows:
§ 721.10016
Dibenzimidazothianaphthalene (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as
dibenzimidazothianaphthalene (PMN
P–01–111) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 17. By adding new § 721.10017 to
subpart E to read as follows:
§ 721.10017 Amine terminated bisphenol A
diglycidyl ether polymer (generic).
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as amine terminated
bisphenol A diglycidyl ether polymer
(PMNs P–01–257/258/259 and P–01–
261) are subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
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(i) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 18. By adding new § 721.10018 to
subpart E to read as follows:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 20. By adding new § 721.10020 to
subpart E to read as follows:
§ 721.10018 Calcium hydroxide oxide
silicate (Ca6(OH)2O2(Si2O5)3).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
calcium hydroxide oxide silicate
(Ca6(OH)2O2(Si2O5)3) (PMN P–01–442;
CAS No. 13169–90–9) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f), (j) (use other
than as filler to reinforce resins, additive
for resins, and filter medium), (v)(1),
and (x)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 19. By adding new § 721.10019 to
subpart E to read as follows:
§ 721.10020 Benzoic acid, 5-amino-2chloro-, 1,1-dimethyl-2-oxo-2-(2propenyloxy) ethyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzoic acid, 5-amino-2-chloro-, 1,1dimethyl-2-oxo-2-(2-propenyloxy) ethyl
ester (PMN P–01–564; CAS No. 174489–
43–1) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 21. By adding new § 721.10021 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10019 Benzoic acid, 2-chloro-5-nitro, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl
ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzoic acid, 2-chloro-5-nitro-, 1,1dimethyl-2-oxo-2-(2-propenyloxy) ethyl
ester (PMN P–01–563; CAS No. 174489–
76–0) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
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§ 721.10021 Magnesium potassium
titanium oxide.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
magnesium potassium titanium oxide
(PMN P–01–764; CAS No. 39290–90–9)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(4), (a)(6)(i), (b) (concentration set at
0.1 percent), and (c). The following
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National Institute for Occupational
Safety and Health (NIOSH)-approved
respirators with an assigned protection
factor (APF) of 10–25 meet the
minimum requirements for
§ 721.63(a)(4): Air-purifying, tight-fitting
respirator equipped with N100 (if
aerosols absent), R100, or P100 filters
(either half- or full-face); powered airpurifying respirator equipped with a
loose-fitting hood or helmet and High
Efficiency Particulate Air (HEPA) filters;
powered air-purifying respirator
equipped with a tight-fitting facepiece
(either half- or full-face) and HEPA
filters; and supplied-air respirator
operated in pressure demand or
continuous flow mode and equipped
with a hood or helmet or tight-fitting
facepiece (either half- or full-face). As
an alternative to the respiratory
requirements listed here, a
manufacturer, importer, or processor
may choose to follow the new chemical
exposure limit (NCEL) provisions listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 5 mg/
m3 as an 8-hour time-weighted average.
Persons who wish to pursue NCELs as
an alternative to the § 721.63 respirator
requirements may request to do so
under 40 CFR 721.30. Persons whose
§ 721.30 requests to use the NCELs
approach are approved by EPA will
receive NCELs provisions comparable to
those contained in the corresponding
section 5(e) consent order.
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set 0.1
percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv)
(use respiratory protection or maintain
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 5 mg/m3) and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(q).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (f), (g), (h), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
22. By adding new § 721.10022 to
subpart E to read as follows:
I
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§ 721.10024 10H-Phenothiazine, ar-(C9-rich
C8-10-branched alkyl) derivs.
§ 721.10026 Cashew, nutshell liq.,
ethoxylated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenamine, N-phenyl-, ar′-(C9-rich
C8-10-branched alkyl) derivs (PMN P–
01–769; CAS No. 333955–69–4) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (antioxidant for
lubricating oils).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 23. By adding new § 721.10023 to
subpart E to read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
10H-phenothiazine, ar-(C9-rich C8-10branched alkyl) derivs (PMN P–01–771;
CAS No. 333955–79–6) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (antioxidant for
lubricating oils).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 25. By adding new § 721.10025 to
subpart E to read as follows:
§ 721.10023 Benzenamine, N-phenyl-, ar
ar′-(C9-rich C8-10-branched alkyl) derivs.
cprice-sewell on PROD1PC61 with RULES
§ 721.10022 Benzenamine, N-phenyl-, ar′(C9-rich C8-10-branched alkyl) derivs.
§ 721.10025 10H-Phenothiazine, ar, ar′-(C9rich C8-10-branched alkyl) derivs.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cashew, nutshell liq., ethoxylated (PMN
P–01–856; CAS No. 350820–95–0) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (any
manufacturing, processing, or use of the
PMN substance with less than 55 moles
of the ethoxy or with an average
molecular weight less than 2,700
daltons).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 27. By adding new § 721.10027 to
subpart E to read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenamine, N-phenyl-, ar,ar′-(C9-rich
C8-10-branched alkyl) derivs (PMN P–
01–770; CAS No. 333955–70–7) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (antioxidant for
lubricating oils).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 24. By adding new § 721.10024 to
subpart E to read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
as 10H-phenothiazine, ar, ar′-(C9-rich
C8-10-branched alkyl) derivs (PMN P–
01–772; CAS No. 333955–80–9) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (antioxidant for
lubricating oils).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 26. By adding new § 721.10026 to
subpart E to read as follows:
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§ 721.10027 Ethoxylated alkylsulfate,
substituted alkylamine salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated alkylsulfate,
substituted alkylamine salt (PMN P–01–
862) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
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28. By adding new § 721.10028 to
subpart E to read as follows:
I
§ 721.10028 Disubstituted benzene metal
salts (generic).
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as disubstituted benzene
metal salts (PMNs P–01–901 and P–01–
902) are subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1) and (a)(3).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (e), and (i) are applicable
to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 29. By adding new § 721.10029 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10029 Isocyanate compound,
modified with methoxysilane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanate compound,
modified with methoxysilane (PMN P–
01–918) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii),
(a)(2)(iv), (a)(3), (a)(4), and (a)(6). The
following National Institute for
Occupational Safety and Health
(NIOSH)-approved respirators meet the
minimum requirement for
§ 721.63(a)(4): Air-purifying, tight-fitting
full-face respirator equipped with N100
(if oil aerosols absent), R100, or P100
filters; powered air-purifying respirator
equipped with a tight-fitting full
facepiece and High Efficiency
Particulate Air (HEPA) filters; suppliedair respirator operated in pressure
demand or continuous flow mode and
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equipped with a tight-fitting full
facepiece. As an alternative to the
respiratory requirements listed here, a
manufacturer, importer, or processor
may choose to follow the new chemical
exposure limit (NCEL) provisions listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.05 mg/
m3 as an 8-hour time-weighted average.
Persons who wish to pursue NCELs as
an alternative to the § 721.63 respirator
requirements may request to do so
under 40 CFR 721.30. Persons whose
§ 721.30 requests to use the NCELs
approach are approved by EPA will
receive NCELs provisions comparable to
those contained in the corresponding
section 5(e) consent order.
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set 1.0
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iv) (use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.05
mg/m3), (g)(2)(v), and (g)(5). The
following statements shall appear on
each label as specified in § 721.72(b)
and the Material Safety Data Sheet
(MSDS) as specified in § 721.72(c): This
substance may cause skin irritation and
sensitization.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(q).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (e), (f), (g), (h), and (i)
are applicable to manufacturers,
importers, and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 30. By adding new § 721.10030 to
subpart E to read as follows:
§ 721.10030 Pyrimido[5,4-g]pteridine2,4,6,8-tetramine, 4methylbenzenesulfonate, base-hydrolyzed.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
pyrimido[5,4-g]pteridine-2,4,6,8tetramine, 4-methylbenzenesulfonate,
base-hydrolyzed (PMN P–01–919; CAS
No. 346709–25–9) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
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14703
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 31. By adding new § 721.10031 to
subpart E to read as follows:
§ 721.10031
oxide.
Lithium potassium titanium
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
lithium potassium titanium oxide (PMN
P–02–214; CAS No. 39318–30–4) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(4), (a)(6)(i), (b) (concentration set at
0.1 percent), and (c). The following
National Institute for Occupational
Safety and Health (NIOSH)-approved
respirators with an APF of 10–25 meet
the minimum requirements for
§ 721.63(a)(4): Air-purifying, tight-fitting
respirator (either half- or full-face)
equipped with N100 (if aerosols absent),
R100, or P100 filters; powered airpurifying, respirator equipped with a
loose-fitting hood or helmet or tightfitting facepiece (either half- or full-face)
and High Efficiency Particulate Air
(HEPA) filters; and supplied-air
respirator operated in pressure demand
or continuous flow mode and equipped
with a hood or helmet or tight-fitting
facepiece (either half- or full-face). As
an alternative to the respiratory
requirements listed here, a
manufacturer, importer, or processor
may choose to follow the new chemical
exposure limit (NCEL) provisions listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 5 mg/
m3 as an 8-hour time-weighted average.
Persons who wish to pursue NCELs as
an alternative to the § 721.63 respirator
requirements may request to do so
under 40 CFR 721.30. Persons whose
§ 721.30 requests to use the NCELs
approach are approved by EPA will
receive NCELs provisions comparable to
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those contained in the corresponding
section 5(e) consent order.
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set 0.1
percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv)
(use respiratory protection or maintain
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 5 mg/m3), and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(q).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (f), (g), (h), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 32. By adding new § 721.10032 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10032 Acrylic acid, polymer with
substituted acrylamides (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acrylic acid, polymer with
substituted acrylamides (PMN P–02–
269) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (any
manufacturing, processing, or use of the
PMN substance with an aerodynamic
diameter less than 10 microns).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 33. By adding new § 721.10033 to
subpart E to read as follows:
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§ 721.10033 Zinc, [ethanedioato(2-)-.
kappa. O1, . kappa. O2]-.
§ 721.10035
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
zinc, [ethanedioato(2-)-. kappa. O1, .
kappa. O2]- (PMN P–02–322; CAS No.
547–68–2) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 34. By adding new § 721.10034 to
subpart E to read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylbenzene sulfonate
(PMN–02–382) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacture,
import, or processing of the chemical
without 19 percent or more mineral oil
as a diluent).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.10034 Substituted pyridine coupled
with diazotized substituted
nitrobenzonitrile, diazotized substituted
benzenamine and substituted
pyridinecarbonitrile (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted pyridine
coupled with diazotized substituted
nitrobenzonitrile, diazotized substituted
benzenamine and substituted
pyridinecarbonitrile (PMN P–02–359) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 35. By adding new § 721.10035 to
subpart E to read as follows:
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Alkylbenzene sulfonate
36. By adding new § 721.10036 to
subpart E to read as follows:
I
§ 721.10036
(generic).
Acetaldehyde based polymer
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acetaldehyde based
polymer (PMN P–02–406) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f).
(ii) Release to water. Requirements as
specified § 721.90 (b)(1) and (c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
37. By adding new § 721.10037 to
subpart E to read as follows:
I
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§ 721.10037 Complex halogenated salt of
tris(ethylatedaminocarbocyclic)methane
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as complex halogenated salt
of
tris(ethylatedaminocarbocyclic)methane
(PMN P–02–423) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (d) and (e).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 38. By adding new § 721.10038 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10038 Trimellitic anhydride, polymer
with substituted glycol, alkyl phenols and
ethoxylated nonylphenol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as trimellitic anhydride,
polymer with substituted glycol, alkyl
phenols and ethoxylated nonylphenol
(PMN P–02–434) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 39. By adding new § 721.10039 to
subpart E to read as follows:
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§ 721.10039 Diethoxybenzenamine
derivative, diazotized, coupled with
aminonaphthalenesulfonic acid derivative,
ammonium salt (generic).
§ 721.10041 1-Butanone, 2(dimethylamino)-2-[(4methylphenyl)methyl]-1-[4-(4morpholinyl)phenyl]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as a diethoxybenzenamine
derivative, diazotized, coupled with
aminonaphthalenesulfonic acid
derivative, ammonium salt (PMN P–02–
514) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f), (v)(2), and
(x)(2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 40. By adding new § 721.10040 to
subpart E to read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-butanone, 2-(dimethylamino)-2-[(4methylphenyl)methyl]-1-[4-(4morpholinyl)phenyl]-(PMN P–02–530;
CAS No. 119344–86–4) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 42. By adding new § 721.10042 to
subpart E to read as follows:
§ 721.10040 Substituted acridine naphtha
substituted benzamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as a substituted acridine
naphtha substituted benzamide (PMN
P–02–522) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(4), (b)(4), and
(c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply tothis section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 41. By adding new § 721.10041 to
subpart E to read as follows:
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§ 721.10042 2-Propanol, 1-[bis(2hydroxyethyl)amino]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propanol, 1-[bis(2hydroxyethyl)amino]- (PMN P–02–585;
CAS No. 6712–98–7) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 43. By adding new § 721.10043 to
subpart E to read as follows:
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§ 721.10043 Dineopentyl-4-substituted
phthalate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dineopentyl-4-substituted
phthalate (PMN P–02–697) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply tothis section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 44. By adding new § 721.10044 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10044 Metal oxide, modified with
alkyl and vinyl terminated polysiloxanes
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as metal oxide, modified
with alkyl and vinyl terminated
polysiloxanes (PMN P–02–698) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (v)(1), (w)(1), and
(x)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 45. By adding new § 721.10045 to
subpart E to read as follows:
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§ 721.10045 Diazotized substituted
heteromonocycle coupled with naphthalene
sulfonic acid derivative, nickel complex,
alkaline salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as a diazotized substituted
heteromonocycle coupled with
naphthalene sulfonic acid derivative,
nickel complex, alkaline salt (PMN P–
02–737) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f), (v)(2), and
(x)(2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 46. By adding new § 721.10046 to
subpart E to read as follows:
§ 721.10046 Polyaromatic amine
phosphate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyaromatic amine
phosphate (PMN P–02–747) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 47. By adding new § 721.10047 to
subpart E to read as follows:
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§ 721.10047 Polyphosphoric acids,
compds. with piperazine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
a polyphosphoric acids, compds. with
piperazine (PMN P–02–766; CAS No.
383905–85–9) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 48. By adding new § 721.10048 to
subpart E to read as follows:
§ 721.10048
(generic).
Substituted anthraquinone
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted anthraquinone
(PMN P–02–869) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(s) (4,500
kilograms).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 49. By adding new § 721.10049 to
subpart E to read as follows:
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§ 721.10049 Phenol, 4,4′- cyclohexylidene
bis[2-methyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
a phenol, 4,4′- cyclohexylidene bis[2methyl- (PMN P–02–912; CAS No.
2362–14–3) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 50. By adding new § 721.10050 to
subpart E to read as follows:
cprice-sewell on PROD1PC61 with RULES
§ 721.10050 Disubstituted-N′- hydroxybenzenecarboximidamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as disubstituted-N′hydroxy-benzenecarboximidamide
(PMN P–02–929) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 51. By adding new § 721.10051 to
subpart E to read as follows:
§ 721.10051
(generic).
Spiro naphthoxazine
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as spiro naphthoxazine
(PMN P–02–961) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 52. By adding new § 721.10052 to
subpart E to read as follows:
§ 721.10052 Aminoalkyl substituted
alkylphenol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aminoalkyl substituted
alkylphenol (PMN P–02–1088) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
I 53. By adding new § 721.10053 to
subpart E to read as follows:
§ 721.10053
(generic).
Alkyl silane methacrylate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyl silane methacrylate
(PMN P–03–41) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
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14707
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 54. By adding new § 721.10054 to
subpart E to read as follows:
§ 721.10054 Phenol, polymer with
formaldehyde, 3-[(2aminocyclohexyl)amino]-2-hydroxypropyl
ethers.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as a phenol, polymer with
formaldehyde, 3-[(2aminocyclohexyl)amino]-2hydroxypropyl ethers (PMN P–03–43;
CAS No. 452082–53–0) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified § 721.90 (a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
I 55. By adding new § 721.10055 to
subpart E to read as follows:
§ 721.10055 1-Propanaminium, 3-amino-N(carboxymethyl)-N,N-dimethyl-, N-soya acyl
derivs., inner salts.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-propanaminium, 3-amino-N(carboxymethyl)-N,N-dimethyl-, N-soya
acyl derivs., inner salts (PMN P–03–46;
CAS No. 136504–87–5) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
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(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
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56. By adding new § 721.10056 to
subpart E to read as follows:
I
§ 721.10056 Benzenemethanaminium, N(3-aminopropyl)-N,N-dimethyl-, N-soya acyl
derivs., chlorides.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenemethanaminium, N-(3aminopropyl)-N,N-dimethyl-, N-soya
acyl derivs., chlorides (PMN P–03–47;
CAS No. 90194–13–1) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
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(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
[FR Doc. E7–5797 Filed 3–28–07; 8:45 am]
BILLING CODE 6560–50–S
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]]>Agencies
[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Rules and Regulations]
[Pages 14681-14708]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5797]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2003-0063; FRL-7699-5]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances and
Notification on Certain Substances for Which Significant New Use Rules
are Not Being Issued
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is promulgating significant new use rules (SNURs) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 65
chemical substances which were the subject of premanufacture notices
(PMNs). Thirteen of these chemical substances are subject to TSCA
section 5(e) consent orders issued by EPA. This action requires persons
who intend to manufacture, import, or process any of these 65 chemical
substances for an activity that is designated as a significant new use
by this rule to notify
[[Page 14682]]
EPA at least 90 days before commencing that activity. The required
notification will provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit that activity
before it occurs. This direct final rule also provides notification on
two substances for which EPA has decided not to issue significant new
use rules at this time.
DATES: The effective date of this rule is May 29, 2007 without further
notice, unless EPA receives adverse or critical comments, or notice of
intent to submit adverse or critical comments before April 30, 2007.
This rule shall be promulgated for purposes of judicial review at 1
p.m. (e.s.t.) on April 12, 2007.
If EPA receives adverse or critical comments, or notice of intent
to submit adverse or critical comments, on one or more of these SNURs
before April 30, 2007, EPA will withdraw the relevant sections of this
direct final rule before its effective date. EPA will then issue a
proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2003-0063, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2003-0063. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2003-0063. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket's
index available at https://www.regulations.gov. Although listed in the
index, some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
For technical information contact: Karen Chu, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8773; e-mail
address: chu.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
Potentially affected entities may include, but are not limited to:
Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
Chemical manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127 and 19 CFR 127.28. Those persons must certify that the shipment
of the chemical substance complies with all applicable rules and orders
under TSCA, including any SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance
[[Page 14683]]
that is the subject of this rule on or after April 30, 2007 are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see 40 CFR 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of a chemical
substance for any activity designated by these SNURs as a significant
new use. Additional rationale and background to this rule are more
fully set out in the preamble to EPA's first direct final SNUR
published in the Federal Register of April 24, 1990 (55 FR 17376).
Consult that preamble for further information on the objectives,
rationale, and procedures for SNURs and on the basis for significant
new use designations, including provisions for developing test data.
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the chemical substance for that use. The mechanism
for reporting under this requirement is established under 40 CFR part
721.5.
C. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to these SNURs must
comply with the same notice requirements and EPA regulatory procedures
as submitters of PMNs under TSCA section 5(a)(1)(A). In particular,
these requirements include the information submission requirements of
TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA
section 5 (h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40
CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action
under TSCA section 5(e), 5(f), 6, or 7 to control the activities on
which it has received the SNUN. If EPA does not take action, the Agency
is required under TSCA section 5(g) to explain in the Federal Register
its reasons for not taking action.
Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNUR requirements. The EPA policy on import certification appears at 40
CFR part 707, subpart B.
III. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping
requirements for 65 chemical substances under 40 CFR part 721, subpart
E. In this unit, EPA provides the following information for each
chemical substance:
PMN number.
Chemical name (generic name if the specific name is
claimed as CBI).
CAS number (if assigned for non-confidential chemical
identities).
Basis for the section 5(e) consent order, or, for non-5(e)
SNURs, the basis for the SNUR.
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VI. for more information).
CFR citation assigned in the regulatory text section of
this rule.
The specific activities designated as significant new uses are
listed in the regulatory text section of 40 CFR part 721, subpart E.
Certain new uses, including production limits and other uses designated
in the rule are claimed as CBI. The procedure for obtaining
confidential information is set out in Unit VII.
This rule includes SNURs on 13 PMN substances that are subject to
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I)
wherein EPA determined that activities associated with the PMN
substances may present unreasonable risk to health or the environment.
The consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these substances are promulgated pursuant to 40 CFR
721.160, and are based on and consistent with the provisions in the
underlying consent orders. The SNURs designate as a ``significant new
use'' the absence of the protective measures required in the consent
order.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via
[[Page 14684]]
inhalation exposure, the underlying section 5(e) consent order usually
requires, among other things, that potentially exposed employees must
wear specified respirators unless actual measurements of the workplace
air show that air-borne concentrations of the PMN substance are below a
New Chemical Exposure Limit (NCEL) that is established by EPA to
provide adequate protection to human health. In addition to the actual
NCEL concentration, the comprehensive NCELs provisions in section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCELs provisions currently exist
in 40 CFR part 721, subpart B for SNURs. Therefore, for these cases,
the individual SNURs in subpart E state that persons subject to the
SNUR who wish to pursue NCELs as an alternative to the Sec. 721.63
respirator requirements may request to do so under 40 CFR 721.30.
Persons whose Sec. 721.30 requests to use the NCELs approach are
approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order for the same
chemical substance for SNURs.
This rule also includes SNURs on 52 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, EPA
did not find that the use scenario described in the PMN triggered the
determinations set forth under section 5(e) of TSCA. EPA, however, does
believe that certain changes from the use scenario described in the PMN
could result in increased exposures, thereby constituting a
``significant new use.'' These so called ``Non-5(e) SNURs'' are
promulgated pursuant to 40 CFR 721.170. EPA has determined that every
activity designated as a ``significant new use'' in all non-5(e) SNURs
issued under 40 CFR 721.170 satisfies the two requirements stipulated
in Sec. 721.170(c)(2), i.e., these significant new use activities,
``(i) are different from those described in the premanufacture notice
for the substance, including any amendments, deletions, and additions
of activities to the premanufacture notice, and (ii) may be accompanied
by changes in exposure or release levels that are significant in
relation to the health or environmental concerns identified'' for the
PMN substance.
PMN Number P-97-415
Chemical name: 2-Thiazolidinone.
CAS number: 2682-49-7.
Effective date of section 5(e) consent order: April 20, 2000.
Basis for section 5(e) consent order: The PMN states that the substance
will be used as an intermediate. The order was issued under section
5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this
substance may present an unreasonable risk of injury to health and the
environment. To protect against this risk, the consent order requires
worker protection and hazard communication and restricts disposal,
water releases, and aggregate manufacture/importation volume of the PMN
substance. It also prohibits use of the PMN substance other than as an
intermediate and prohibits domestic manufacturing, processing, or use
of the PMN substance as a powder. The SNUR designates as a `significant
new use' the absence of these protective measures.
Toxicity concern: EPA has identified health concerns for high acute
toxicity and signs of neurotoxic effects based on test data for the PMN
substance. EPA also has concerns for chronic effects and systemic,
developmental, and maternal toxicity based on test data on a
structurally similar substance. The NCEL is 0.7 mg/m\3\ as an 8-hour
time-weighted average. EPA is concerned that toxicity to aquatic
organisms may occur at concentrations as low as 300 parts per billion
(ppb) of the PMN substance in surface waters based on test data on a
structurally similar substance.
Recommended testing: EPA has determined that the following test would
help characterize the human health effects of the PMN substance: A
combined repeated dose toxicity with the reproductive/developmental
toxicity screening test (oral route) (OPPTS 870.3650 test guideline)
with a neurotoxicity functional observational battery (National
Technical Information Service (NTIS) PB 91-154617) and a
histopathologic examination extended to include the blood, liver,
kidney, brain, and spinal cord on the PMN substance to help
characterize neurotoxic, systemic, reproductive, and developmental
effects. The PMN submitter has agreed not to exceed the production
volume limit without performing this test. In addition, EPA has
determined that a porous pot test (OPPTS 835.3220 test guideline), a
fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline
(public draft)), and an algal toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10002.
PMN Numbers P-98-625/626/627/628/629 and P-00-614/617
Chemical name: Manganese heterocyclic tetraamine complex (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-confidential)
use of the substances will be in commercial research and development.
EPA has identified health concerns for chronic organ effects based on
data on a structurally similar substance. Since significant worker
exposure is unlikely at the production volume identified in the PMNs,
EPA has not determined that the proposed manufacture, processing, or
use of the substances may present an unreasonable risk. EPA has
determined, however, that a manufacture or importation volume greater
than 10,000 kilograms/year of any one of the PMN substances may result
in serious chronic effects. Based on this information, each of the PMN
substances meet the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
oral toxicity study (OPPTS 870.3100 test guideline) would help
characterize the human health effects of the PMN substances.
CFR citation: 40 CFR 721.10003.
PMN Number P-98-1181
Chemical name: 2-Butenoic acid, 4,4'-
[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-
C8-10-isoalkyl esters, C9-rich.
CAS number: 247041-56-1.
Basis for action: The PMN states that the substance will be used as a
polyvinyl chloride stabilizer. EPA has identified concerns for
corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood
toxicity, liver toxicity, immunosupression, reproductive toxicity, and
adrenal effects based on analogy to organotins. As described in the
PMN, significant worker exposure is unlikely. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that uses of the substance in a solid form, involving an
application method that generates a vapor, mist, or aerosol, or where
there is potential dermal exposure without the use of impervious
gloves, may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
[[Page 14685]]
oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity
screening test (OPPTS 870.6200 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10004.
PMN Number P-98-1182
Chemical name: 2-Butenoic acid, 4,4'-
[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-
C9-11-isoalkyl esters, C10-rich.
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
polyvinyl chloride stabilizer. EPA has identified concerns for
corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood
toxicity, liver toxicity, immunosupression, reproductive toxicity, and
adrenal effects based on analogy to organotins. As described in the
PMN, significant worker exposure is unlikely. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that uses of the substance in a solid form, involving an
application method that generates a vapor, mist, or aerosol, or where
there is potential dermal exposure without the use of impervious
gloves, may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity
screening test (OPPTS 870.6200 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10005.
PMN Number P-99-511
Chemical name: Mixed metal oxide (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an
additive for coatings. Based on data for a similar substance, EPA has
identified concerns for cancer, immunotoxicity, and lung toxicity. As
described in the PMN, significant inhalation exposure is unlikely.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that a manufacture/importation volume
greater than 60,000 kilograms/year of the PMN substance may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C) and
(b)(3)(ii).
Recommended testing: EPA has determined that a bacterial reverse
mutation test (OPPTS 870.5100 test guideline) and a mammalian
erythrocyte micronucleus test (intraperitoneal route) (OPPTS 870.5395
test guideline) with special attention to histopathology of the lung
tissues and organs of the immune systems (spleen, thymus, bone marrow)
would help characterize the human health effects of the PMN substance.
If the results of the recommended tests indicate that the PMN substance
has carcinogenic potential, a carcinogenicity study (OPPTS 870.4200
test guideline) would help further characterize the health effects.
CFR citation: 40 CFR 721.10006.
PMN Number P-00-11
Chemical name: Alcohols, C12-14 - secondary, ethoxylated
propoxylated.
CAS number: 103331-86-8.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a household cleaning agent additive.
Based on analogy to nonionic surfactants, EPA is concerned that
toxicity to aquatic organisms may occur at concentrations above 50 ppb
in surface waters. As described in the PMN, releases of the substance
are not expected to result in surface water concentrations above 50
ppb. Thus, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in surface water concentrations above 50 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity test (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10007.
PMN Numbers P-00-1121/1122/1123/1124/1125/1126
Chemical names: (P-00-1121) Manganese strontium oxide
(MnSrO3); (P-00-1122) Manganese yttrium oxide
(MnYO3); (P-00-1123) Barium manganese oxide
(BaMnO3); (P-00-1124) Barium calcium manganese strontium
oxide; (P-00-1125) Manganate (MnO2\1\-), calcium
(2:1); and (P-00-1126) Manganese yttrium oxide
(Mn2YO5).
CAS numbers: (P-00-1121) 12163-45-0, (P-00-1122) 12032-75-6, (P-00-
1123) 12230-80-7, (P-00-1124) 359427-90-0, (P-00-1125) 12049-47-7, and
(P-00-1126) 12438-71-0.
Effective date of section 5(e) consent order: March 23, 2001.
Basis for section 5(e) consent order: The PMNs state that the generic
(non-confidential) use of the substances will be as pigments. The order
was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA
based on a finding that these substances may present an unreasonable
risk of injury to human health and the environment. To protect against
this risk, the consent order requires hazard communication and
restricts aggregate manufacture/importation volume, particle size and
water releases of the PMN substances. The SNUR designates as a
`significant new use' the absence of these protective measures.
Toxicity concern: EPA has health concerns for neurotoxicity and
mutagenicity for the PMN substances based on exposure to manganese;
concerns for lung toxicity, fibrosis, and possible cancer of the lungs
due to potential exposure to the particulate form of the substances;
and concern for lung effects through lung overload if respirable
particles are inhaled. Based on test data on structurally similar
substances, EPA is concerned that toxicity to aquatic organisms for
each of these PMN substances may occur at concentrations as low as 100
ppb in surface waters. Further, the Agency has determined that the PMN
substances may be persistant, bioaccumulative, and toxic based on
physical/chemical properties of the substances, consistent with the New
Chemical Program's Persistant, Bioaccumulative, and Toxic (PBT)
Category (64 FR 60194, November 4, 1999) (FRL-6097-7). Because of the
potential PBT nature of the PMN substances, bioaccumulation and the
potential for eventual exposure to humans and wildlife could result
from exposure to concentrations below 100 ppb. Therefore, to adequately
mitigate this concern, EPA has decided to limit surface water
concentrations resulting from manufacturing, processing, or use to 1
ppb or less for each of the PMN substances.
Recommended testing: EPA has determined that a fish bioconcentration
factor (BCF) test (OPPTS 850.1730 test guideline (public draft)) would
help characterize the environmental effects of the substances. The PMN
submitter has
[[Page 14686]]
agreed not to exceed the production volume limit without performing the
fish BCF test on P-00-1122 or P-00-1126. EPA has determined that a 90-
day inhalation toxicity study in rats with a 60-day holding period with
special attention to the histopathology of the lungs (OPPTS 870.3465
test guideline) would help characterize the human health effects of the
PMN substances. Based on the results of the 90-day study, a 2-year
inhalation carcinogenicity test (OPPTS 870.4200 test guideline) may be
warranted.
CFR citations: 40 CFR 721.10008 (P-00-1121); 40 CFR 721.10009 (P-00-
1122); 40 CFR 721.10010 (P-00-1123); 40 CFR 721.10011 (P-00-1124); 40
CFR 721.10012 (P-00-1125); and 40 CFR 721.10013 (P-00-1126).
PMN Number P-01-109
Chemical name: Halogenated naphthalic anhydride (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
dye intermediate. Based on toxicity data on structurally similar
chemicals, EPA expects toxicity to aquatic organisms to occur at
concentrations as low as 20 ppb of the PMN substance in surface waters.
As described in the PMN, the substance is not released to surface
waters. Therefore, EPA has not determined that the proposed processing
or use of the substance may present an unreasonable risk. EPA has
determined, however, that releases to surface waters may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following testing would help characterize the PMN substance: An algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and
a fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)).
CFR citation: 40 CFR 721.10014.
PMN Number P-01-110
Chemical name: Halogenated benzimidazole (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
dye intermediate. Based on Structure Activity Relationships (SAR)
analysis, EPA expects toxicity to aquatic organisms to occur at
concentrations as low as 1 ppb of the PMN substance in surface waters.
In addition, EPA has identified environmental concerns because the PMN
substance may be persistent, bioaccumulative, and toxic based on
physical/chemical properties of the PMN substance, consistent with the
New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As
described in the PMN, the substance is not released to surface waters.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in release of the PMN substance to surface waters may cause significant
adverse environmental effects, since the PMN substance has been
characterized by EPA as a PBT. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tiered testing would help characterize the PMN substance:
Tier 1 - Melting point/melting range test (OPPTS 830.7200 test
guideline) and an octanol water partition coefficient/Kow
test (OPPTS 830.7550 test guideline); Tier 2 - Activated sludge
sorption isotherm (OPPTS 835.1110 test guideline) or modified
coagulation-flocculation jar test of water (D2034-80); Tier 3 - An
algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a
daphnid acute toxicity test (OPPTS 850.1010 test guideline (public
draft)) and a fish acute toxicity test (OPPTS 850.1075 test guideline
(public draft)); Tier 4 - tiered testing as described in the New
Chemicals Program's PBT Category (excluding the octanol water partition
coefficient/Kow test already recommended in Tier 1).
CFR citation: 40 CFR 721.10015.
PMN Number P-01-111
Chemical name: Dibenzimidazothianaphthalene (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
fluorescent dye. Based on toxicity data on structurally similar
chemicals, EPA expects chronic toxicity to aquatic organisms to occur
at concentrations as low as 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
processing or use of the substance may present an unreasonable risk.
EPA has determined, however, that releases to surface waters may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tiered testing would help characterize the PMN substance:
Tier 1 - Activated sludge sorption isotherm test (OPPTS 835.1110 test
guideline) or modified coagulation-flocculation jar test of water
(D2034-80); Tier 2 - An algal toxicity test (OPPTS 850.5400 test
guideline (public draft)), a daphnid acute toxicity test (OPPTS
850.1010 test guideline (public draft)), and a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)); and Tier 3 - A daphnid
chronic toxicity test (OPPTS 850.1300 test guideline (public draft))
and a fish early-life stage toxicity test (OPPTS 850.1400 test
guideline (public draft)).
CFR citation: 40 CFR 721.10016.
PMN Numbers P-01-257/258/259 and P-01-261
Chemical name: Amine terminated bisphenol A diglycidyl ether polymer
(generic).
CAS number: Not available.
Basis for action: The PMNs state that the substances will be used as
epoxy resin curing agents. Based on analogy to structurally similar
polycationic polymers, EPA is concerned that toxicity to aquatic
organisms may occur at concentrations as low as 40 ppb in surface
waters. As described in the PMNs, the substances are not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that other uses of the
substances resulting in release to surface waters may cause significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish
acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and
a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test
guideline (public draft)) would help characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.10017.
PMN Number P-01-442
Chemical name: Calcium hydroxide oxide silicate
(Ca6(OH)2O2(Si2O5
)3).
CAS number: 13169-90-9.
Basis for action: The PMN states that the substance will be used as a
filler to reinforce resins, an additive for resins, and a filter
medium. Based on test data on this chemical and structurally similar
compounds, EPA has identified
[[Page 14687]]
human health concerns for cancer and toxicity to the respiratory tract,
lungs, respiratory system, and liver to workers exposed via inhalation.
As described in the PMN, significant worker exposure is unlikely.
Therefore, EPA has not determined that the proposed import, processing,
or use of the substance may present an unreasonable risk. EPA has
determined, however, that domestic manufacture, uses other than as
described in the PMN, or processing or use as a powder resulting in
significant worker inhalation exposure may cause significant adverse
human health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(3)(i),
and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity study (OPPTS 870.3465 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10018.
PMN Number P-01-563
Chemical name: Benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-
(2-propenyloxy) ethyl ester.
CAS number: 174489-76-0.
Basis for action: The PMN states that the substance will be used as a
chemical intermediate. Based on submitted test data and on structural
analogy to esters, EPA is concerned that toxicity to aquatic organisms
may occur at concentrations as low as 3 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in release to surface waters may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), and an
aerobic aquatic biodegradation test with an analytical methodology to
identify the isononyl phenol degradation product (OPPTS 835.3100 test
guideline) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10019.
PMN Number P-01-564
Chemical name: Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-
(2-propenyloxy) ethyl ester.
CAS number: 174489-43-1.
Basis for action: The PMN states that the substance will be used as a
chemical intermediate. Based on structural analogy to anilines, EPA is
concerned that toxicity to aquatic organisms may occur at
concentrations as low as 1 ppb of the PMN substance in surface waters.
As described in the PMN, the substance is not released to surface
waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in release to surface waters may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), and an
aerobic aquatic biodegradation test with an analytical methodology to
identify the isononyl phenol degradation product (OPPTS 835.3100 test
guideline) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10020.
PMN Number P-01-764
Chemical name: Magnesium potassium titanium oxide.
CAS number:39290-90-9.
Effective date of section 5(e) consent order: July 29, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a physical
characteristics modifier for industrial use in certain solid composite
articles. The order was issued under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may
present an unreasonable risk of injury to human health. To protect
against this risk, the consent order requires worker protection and
hazard communication and restricts the aggregate manufacture/
importation volume of the PMN substance. The SNUR designates as a
`significant new use' the absence of these protective measures.
Toxicity concern: Based on test data on titanium dioxide, EPA has
health concerns for lung toxicity, including lung overload and
oncogenicity, with inhalation exposure. The NCEL is 5 mg/m\3\ as an 8-
hour time-weighted average.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study with a 60-day holding period (OPPTS 870.3465
test guideline) and possibly a 2-year carcinogenicity study (OPPTS
870.4200 test guideline) would help characterize the human health
effects of the PMN substance. The consent order contains two production
volume limits. The PMN submitter agreed not to exceed the first
production volume limit without performing the 90-day inhalation
toxicity study and not to exceed the second production volume limit
without performing the 2-year carcinogenicity study if warranted based
on the results of the first study.
CFR citation: 40 CFR 721.10021.
PMN Numbers P-01-769/770/771/772
Chemical names: (P-01-769) Benzenamine, N-phenyl-, ar-(C9-
rich C8-10-branched alkyl) derivs; (P-01-770) Benzenamine,
N-phenyl-, ar, ar'-(C9-rich C8-10-branched alkyl)
derivs; (P-01-771) 10H-Phenothiazine, ar-(C9-rich
C8-10-branched alkyl) derivs; and (P-01-772) 10H-
Phenothiazine, ar, ar'-(C9-rich C8-10-branched
alkyl) derivs.
CAS numbers: (P-01-769) 333955-69-4, (P-01-770) 333955-70-7, (P-01-771)
333955-79-6, and (P-01-772) 333955-80-9.
Basis for action: The PMNs state that the substances will be used as
antioxidants for lubricating oils. EPA has identified human health and
environmental concerns because the PMN substances may be persistent,
bioaccumulative, and toxic, based on submitted test data and physical/
chemical properties of the PMN substances, consistent with the New
Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As
described in the PMNs, significant worker exposure is unlikely and the
substances are not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
PMN substances may present an unreasonable risk. EPA has determined,
however, that use of the PMN substances other than as described in the
PMNs resulting in release to water may cause serious chronic human
health effects and significant environmental effects, since the PMN
substances have been characterized by EPA as a PBT. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170 (b)(3)(i), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of testing
Tiers 2 and 3 as described in the New
[[Page 14688]]
Chemicals Program's PBT Category would help characterize the PBT
attributes of the PMN substances.
CFR citations: 40 CFR 721.10022 (P-01-769); 40 CFR 721.10023 (P-01-
770); 40 CFR 721.10024 (P-01-771); and 40 CFR 721.10025 (P-01-772).
PMN Number P-01-856
Chemical name: Cashew, nutshell liq., ethoxylated.
CAS number: 350820-95-0.
Effective date of section 5(e) consent order: July 5, 2002.
Basis for section 5(e) consent order: The PMN states that the substance
will be used as a pigment dispersant. The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to the
environment. To protect against this risk, the consent order restricts
molecular weight and composition of the PMN substance. The SNUR
designates as a `significant new use' the absence of these protective
measures.
Toxicity concern: Based on test data on structurally similar nonionic
surfactants, particularly alkyl ethoxylate, EPA has concerns that the
environmental toxicity of the PMN substance varies depending on the
average number of moles of the ethoxy. As the number of moles of ethoxy
decreases, the aquatic toxicity of the substance increases. For this
PMN substance, the average number of moles may vary. When the average
number of moles of the ethoxy group is 80, EPA expects toxicity to
aquatic organisms to occur at concentrations as low as 1,000 ppb.
Recommended testing: The Agency has determined that the results of a
fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline
(public draft)), and an algal toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help characterize possible
environmental effects of the substance. The tests should be conducted
on the PMN substance with less than 55 moles of the ethoxy group or
with an average molecular weight less than 2,700 daltons.
CFR citation: 40 CFR 721.10026.
PMN Number P-01-862
Chemical name: Ethoxylated alkylsulfate, substituted alkylamine salt
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a processing aid. Based on analogy to
cationic surfactants and similar substances, EPA is concerned that
chronic toxicity to aquatic organisms may occur at concentrations as
low as 4 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not released to surface waters in significant
quantities. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in significant release to surface waters may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish early-life stage
toxicity test (OPPTS 850.1400 test guideline (public draft)), a daphnid
chronic toxicity test (OPPTS 850.1300 test guideline (public draft)),
and a ready biodegradability test (OPPTS 835.3110 test guideline) would
help characterize the chronic environmental effects and the fate in the
environment of the PMN substance. After this testing is completed, if
the results of the testing and projected environmental risk warrant it,
a porous pot test (OPPTS 835.3220 test guideline) or modified semi-
continuous activated sludge (SCAS) test (OPPTS 835.3210 test guideline)
would further characterize the environmental fate of this substance.
CFR citation: 40 CFR 721.10027.
PMN Numbers P-01-901 and P-01-902
Chemical name: Disubstituted benzene metal salt (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-confidential)
use of the substances will be as a polymer additive. Based on test data
and analogy to phenols and hydroquinones/quinones, EPA has concerns for
dermal corrosivity, acute toxicity, kidney and liver effects,
mutagenicity, carcinogenicity, neurotoxicity, developmental toxicity,
depigmentation of skin, thyroid effects, and sensitization. Also, based
on analogy to phenols and hydroquinones/quinones, EPA is concerned that
toxicity to aquatic organisms may occur at concentrations as low as 1
ppb in surface waters. As described in the PMNs, significant worker
exposure is not expected as workers wear impervious personal protective
equipment and significant environmental exposure is not expected as the
substances are not released to surface waters in significant
quantities. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that use of the
substances without workers wearing impervious gloves or uses other than
as described in the PMNs could result in serious health effects or
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec. 721.170
(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity test (OPPTS 850.1075 test guideline (public draft))
would help characterize the environmental effects of the PMN
substances. EPA has also determined that a 90-day inhalation toxicity
study with a 60-day holding period (OPPTS 870.3465 test guideline)
would help characterize the human health effects.
CFR citation: 40 CFR 721.10028.
PMN Number P-01-918
Chemical name: Isocyanate compound, modified with methoxysilane
(generic).
CAS number: Not available.
Effective date of section 5(e) consent order: May 30, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a sealant. The order
was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA
based on a finding that this substance may present an unreasonable risk
of injury to human health. To protect against this risk, the consent
order requires worker protection and hazard communication and restricts
the aggregate manufacture/importation volume of the PMN substance. The
SNUR designates as a `significant new use' the absence of these
protective measures.
Toxicity concern: Based on test data on diisocyanates, the Agency has
concern for dermal and respiratory sensitization and pulmonary
toxicity. The NCEL is 0.05 mg/m\3\ or 0.005 ppm as an 8-hour time-
weighted average.
Recommended testing: EPA has determined that the results of a skin
sensitization study (OPPTS 870.2600 test guideline) and a 90-day
inhalation toxicity study (OPPTS 870.3465 test guideline) would help
characterize the human health effects of the substance.
CFR citation: 40 CFR 721.10029.
PMN Number P-01-919
Chemical name: Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-
methylbenzenesulfonate, base-hydrolyzed.
[[Page 14689]]
CAS number: 346709-25-9.
Basis for action: The PMN states that the substance will be used as a
pigment for thermoplastic polymers. Based on analogy to structurally
similar N-heterocyclic chemicals, EPA has concerns for potential
developmental toxicity from exposure to the PMN material. Significant
worker exposure is unlikely when the substance is used as described in
the PMN. In addition, based on test data on the PMN substance, EPA is
concerned that chronic toxicity to aquatic organisms may occur at
concentrations as low as 10 ppb in surface waters. As described in the
PMN, the substance is not released to surface waters in significant
quantities. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture of the substance may cause serious health effects and
significant environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and
(b)(4)(i).
Recommended testing: EPA has determined that a combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test (OPPTS 870.3650 test guideline), a daphnid chronic toxicity test
(OPPTS 850.1300 test guideline (public draft)), and a fish early-life
stage toxicity test (OPPTS 850.1400 test guideline (public draft))
would help characterize the human health and environmental effects of
the substance.
CFR citation: 40 CFR 721.10030.
PMN Number P-02-214
Chemical name: Lithium potassium titanium oxide.
CAS number: 39318-30-4.
Effective date of section 5(e) consent order: June 17, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a physical
characteristics modifier for industrial use in certain solid composite
articles. The order was issued under section 5(e)(1)(A)(i) and
(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may
present an unreasonable risk of injury to human health. To protect
against this risk, the consent order requires worker protection and
hazard communication and restricts the aggregate manufacture/
importation volume of the PMN substance. The SNUR designates as a
`significant new use' the absence of these protective measures.
Toxicity concern: Based on test data on titanium dioxide, the Agency
has concerns for lung toxicity (including oncogenicity) if the PMN
substance is inhaled. The NCEL is 5 mg/m\3\ as an 8-hour time-weighted
average.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study with a 60-day holding period (OPPTS 870.3465
test guideline) and possibly a 2-year carcinogenicity study (OPPTS
870.4200 test guideline) would help characterize the human health
effects of the PMN substance. The consent order contains two production
volume limits. The PMN submitter agreed not to exceed the first
production volume limit without performing the 90-day inhalation
toxicity study and not to exceed the second production volume limit
without performing the 2-year carcinogenicity study if warranted based
on the results of the first study.
CFR citation: 40 CFR 721.10031.
PMN Number P-02-269
Chemical name: Acrylic acid, polymer with substituted acrylamides
(generic).
CAS number: Not available.
Effective date of section 5(e) consent order: October 22, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a thermo-sensitive
water absorbing/desorbing polymer to soil. The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health. To protect against this risk, the consent order restricts the
particle size of the PMN substance. The SNUR designates as a
`significant new use' the absence of this protective measure.
Toxicity concern: Based on test data on swellable high molecular weight
polymers (see 60 FR 16319-16320, March 29, 1995) (FRl-4921-9), the
Agency has concerns for lung toxicity and oncogenicity if the PMN
substance is inhaled.
Recommended testing: The Agency has determined that a 90-day inhalation
toxicity study (OPPTS 870.3465 test guideline) and a carcinogenicity
study (OPPTS 870.4200 test guideline) would help characterize possible
human health effects of the substance.
CFR citation: 40 CFR 721.10032.
PMN Number P-02-322
Chemical name: Zinc, [ethanedioato(2-)-. kappa. O\1\, . kappa. O\2\]-.
CAS number: 547-68-2.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an intermediate. Based on analogy to
similar zinc compounds, EPA is concerned that toxicity to aquatic
organisms may occur at concentrations above 1 ppb in surface waters. As
described in the PMN, releases of the substance are not expected to
result in surface water concentrations above 1 ppb. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the PMN substance may cause significant adverse effects. EPA has
determined, however, that other uses of the PMN substance resulting in
surface water concentrations above 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), a fish
early-life stage toxicity test (OPPTS 850.1400 test guideline (public
draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test
guideline (public draft)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10033.
PMN Number P-02-359
Chemical name: Substituted pyridine coupled with diazotized substituted
nitrobenzonitrile, diazotized substituted benzenamine and substituted
pyridinecarbonitrile (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a textile dye. Based on structural
analogy to neutral organics, EPA is concerned that chronic toxicity to
aquatic organisms may occur at concentrations above 1 ppb of the PMN
substance in surface waters. As described in the PMN, the substance is
not released to surface waters in significant quantities. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance may present an unreasonable risk. EPA has
determined, however, that other uses of the substance resulting in
release to surface waters in concentrations above 1 ppb may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish early-life toxicity
test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic
toxicity test (OPPTS 850.1300 test guideline (public draft)), and an
algal toxicity test (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10034.
PMN Number P-02-382
Chemical name: Alkylbenzene sulfonate (generic).
[[Page 14690]]
CAS number: Not available.
Effective date of section 5(e) consent order: December 17, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a petroleum
lubricant additive. The order was issued under section 5(e)(1)(A)(i)
and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may
present an unreasonable risk of injury to the environment. To protect
against this risk, the consent order restricts the formulation of the
PMN substance. The SNUR designates as a `significant new use' the
absence of this protective measure. In addition, the order was issued
under section 5(e)(1)(A)(ii)(II) of TSCA based on a finding that this
substance will be produced in substantial quantities and may reasonably
be anticipated to enter the environment in substantial quantities.
Toxicity concern: Based on analogy to structurally similar anionic
surfactants, EPA expects toxicity to aquatic organisms to occur at
concentrations as low as 500 ppb in surface waters. However, when the
PMN substance is manufactured, processed, and used in mineral oil as
described in the PMN, EPA does not expect releases of this PMN
substance to pose a risk to the environment. The oil diluent serves to
minimize dispersion and bioavailability of the PMN substance in surface
waters. EPA has determined that other uses of the substance when not
diluted in mineral oil may result in significant release to surface
waters and may cause significant adverse environmental effects.
Recommended testing: EPA has determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity test (OPPTS 850.1075 test guideline (public draft))
would help characterize the environmental effects of the PMN substance
when not used in mineral oil.
CFR citation: 40 CFR 721.10035.
PMN Number P-02-406
Chemical name: Acetaldehyde based polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a corrosion inhibitor. EPA has
identified health and environmental concerns for this substance. EPA
has identified health concerns for carcinogenicity and dermal
sensitization based on analogy to structurally similar chemicals. Based
on structural analogy to aldehydes, EPA is concerned that toxicity to
aquatic organisms may occur at concentrations as low as 1 ppb of the
PMN substance in surface waters. In addition, the PMN substance may be
persistent, bioaccumulative, and potentially toxic based on physical/
chemical properties of the PMN substance as described in the New
Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As
described in the PMN, significant worker exposure is unlikely and the
substance is not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that other domestic manufacturing or other uses that result in
predictable or purposeful releases to surface water could result in
exposures which may cause serious chronic human health effects and
significant environmental effects since the substance has been
characterized by EPA as a PBT. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C),
(b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the tiered
testing as described in the New Chemicals Program's PBT Category would
help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10036.
PMN Number P-02-423
Chemical name: Complex halogenated salt of tris(ethylated
aminocarbocyclic)methane (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
colorant for inks. Based on structurally similar compounds, EPA has
identified human health concerns for carcinogenicity, mutagenicity,
reproductive effects, and developmental effects from inhalation
exposure to the PMN substance. In addition, based on structurally
similar compounds, EPA expects toxicity to aquatic organisms at surface
water concentrations above 1 ppb. As described in the PMN, significant
worker and environmental exposure are unlikely. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in surface water
concentrations above 1 ppb or any processing or use beyond the site of
manufacture or import could result in worker and environmental
exposures which may cause carcinogenic and serious chronic effects in
humans and significant environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(1)(i)(C), (b)(
